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This case study explores the Australian drug discovery landscape with a focus on the Precinct, challenges for Australia’s medical research and biotechnology sector and how Cortellis Drug Discovery Intelligence will help better position the Precinct to accelerate drug discovery and play a more prominent role locally and abroad to compete with leading drug developers.

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Done waiting for Congress to take action on drug prices, states are increasingly enacting laws that create drug affordability review boards. As is done with utilities or insurance premiums, the boards allow states to develop rate-setting programs for certain high cost drugs.

Although Congress has held off from enacting similar laws, Congressional delegations such as Maryland’s are emerging to push for a federal board.

Several states, including California, New Jersey, Oregon, Minnesota, Missouri, Illinois, Massachusetts and Maryland have created affordability review boards. Many of the laws are modeled on California’s (SB 17), enacted in 2019. The California law forces drug manufacturers to announce large price hikes and give detailed justification for their decision to raise prices. Public reports are posted on the state’s Department of Managed Health Care site.

The trade group PhRMA is challenging the California law as unconstitutional in federal court (U.S. District Court, Eastern District of California, case #: 2:17-cv-02573).

California’s law mandates that manufacturers:

• notify the state of marketing and pricing plans used in the launch of a new drug (and they must provide an estimate of the number of patients that might be prescribed the drug);
• notify purchasers before increasing (by more than 16% in a two-year period) the wholesale acquisition cost of a prescription drug that costs more than $40;
• provide the state with a description of factors that led to the decision to increase a drug’s price, including documentation of increased clinical efficacy of the drug; and
• report to the state when introducing a prescription drug that is priced above Medicare’s specialty drug threshold.

States with bills pending in 2021 that would create new drug review boards include: Arizona (SB 1749), Colorado (SB 175) and New Mexico (HB 154).

The boards are essentially a move toward European-style pricing policies with a focus on supply-side regulation. However, unlike European competition law, which includes an analysis of profit margins to determine whether a drug is excessively priced, the states are not including defined profit margins in these policies, which could impact incentives to introduce new drugs profitability in a competitive market.

Ultimately, the federal government may impose rules that fall into step with the plethora of emerging state laws. Harmonization of this issue at the national level would help to reduce confusion and administrative costs for companies selling pharmaceuticals, which, as interstate products, would benefit from uniform regulation.

Insights provided in this article were developed by Clarivate analysts, using data and analysis of the managed care landscape in the United States. Clarivate analysts will continue to keep a close eye on the evolving U.S. market access environment.

Navigate fast-moving dynamics in U.S. markets at the local level and increase treatment access with Clarivate U.S. market access intelligence solutions.

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In 2010, Nick Sireau, a London-based father of two boys with the rare progressive genetic disease alkaptonuria (or AKU, also known as “Black bone disease”), had just quit his job in the NGO sector to focus exclusively on finding treatments for the condition. Like many so-called “kitchen table” patient advocates who were parents of sick kids, he’d poured the whole of his heart, soul, time and savings into the task. Unlike most, he’d already managed to identify a potential treatment, establish a patient group, solicit interest from the scientific community and raise funds for further research through the Royal Liverpool Hospital.

Patent rights to Sireau’s compound of interest, nitisinone, were held by Sobi, and the company had investigated developing it as a treatment for AKU. However, Sobi decided to focus its energies elsewhere following the 2009 failure of an NIH trial plagued by a too-small patient sample and poor endpoint selection. Sireau learned that the president and CEO of Sobi would be attending the inaugural World Orphan Drug Congress meeting in Geneva and set out to talk to him there.

“I contacted them beforehand and said ‘Look, could we please meet up, even just for a few minutes at the coffee break,’” said Sireau, “and we did, and I explained that we had a very good consortium, a good protocol, we had animal models, access to patients and would they be willing to consider working in partnership. And they said ‘Fine, let’s discuss it.’”

The resulting partnership between an international biopharma and a tiny, up-by-its-bootstraps patient organization produced a treatment that won EC approval last October and is now licensed throughout Europe (read this excellent Nature piece for more on Sireau’s nitisinone saga).

But back to that fateful 2010 conference in Geneva. “What surprised me,” said Sireau, “was that I was the only patient group there, and there were 350 pharmaceutical executives, and I was like, ‘I cannot believe that patient groups are not going out to interact.’”

What patients want from life sciences companies

Ten years on, stories like Sireau’s are becoming more commonplace, as genetic medicine advances and more biopharmas focus on rare diseases. The disconnect between companies and patients, however, can often remain substantial even today.

Sireau shared his story in a March 23 panel discussion alongside Henny Braund of Anthony Nolan and Claudia Hirawat of Voz Advisors, facilitated by Mike Ward of Clarivate. The topic: What patients want from life sciences companies. Here are some key takeaways:

Patient groups need help in raising funds, and with navigating regulatory systems and research worlds.

“In the early days, we were at sea,” said Sireau. “One of the things I realized is that even though in every rare disease the symptoms are very different, the challenges you face as a patient group are pretty much identical. It’s where do you get the funds, how do you identify the patients, how do you get them together as a community, how do you do the natural history studies, how do you work with them as an industry, what’s the regulatory process.”

Sireau proposes that patients and companies establish an independent foundation to distribute funds from industry to patient groups. “That would benefit everybody, because a well-constructed patient group can work absolute wonders when it comes to developing new treatments.”

Data-sharing can benefit patients and life science companies alike. Henny Braund, CEO of Anthony Nolan and the Association of Medical Research Charities, shared an example of a data partnership between Janssen and the Blood Cancer Alliance in the United Kingdom.“

There was a lack of a complete picture about hematological disorders,” said Braund, “so Janssen funded all of that data coming together in one place,” giving patient groups and the government a better view of the scope of the condition.

“Data is also power,” said Braund. “This isn’t just about the patient voice in terms of us getting their insights or experiences, it’s thinking about where there’s an unmet need that would actually help that community.”

Sharing power and decision-making with patients is essential. “This has to be seen as a true partnership,” said Braund, “and it’s a value set – it isn’t about profit. It’s about getting the best for that patient. Partnership means equal, doesn’t it?”

Patient centricity needs to be “a discipline across all stages,” said Claudia Hirawat, of Voz Advisors, “a procedure that’s systemic, that’s done across every single program of your portfolio.” Hirawat shared the example of Takeda, whose patient engagement office pulls the patient voice into functions throughout the company.

“It has to start with a partnership, and it has to start at the beginning. There isn’t one size that fits all. Just running a patient panel isn’t the answer to this. You have to think of different ways of bringing patients to the table.”

Too many companies remain reticent to engage with patients and their advocates, for reasons ranging from a sometimes paternalistic corporate culture to fear of raising unmanageable expectations among patients, panelists said.“It is still a lot of underestimating the knowledge these groups have and their capability to be real partners,” said Henny, “and once companies have the courage to enter into these relationships, they’re usually extremely surprised, and those fears tend to dissipate naturally.”

View the entire hourlong conversation here, and don’t miss the next installment in our ongoing series on patient centricity, a conversation about achieving data-driven patient centricity at scale, on Thursday, May 20. You can register for that webinar here.  

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The Republic of Singapore is a sovereign island city-state in Southeast Asia with a total population of 5.7 million. The country has the second highest gross domestic product (GDP) per capita in the world, amounting to SG$82,503 (2020), and health expenditure represents 2.1% (2017). The healthcare system of Singapore is robust and has been ranked the most efficient of the COVID-19 era in the world by Bloomberg.

The system is regulated by the Ministry of Health (MOH), whose goals are to ensure access to good and affordable healthcare, promote good health, reduce illness and pursue medical excellence. This government-run, publicly funded, universal healthcare system is divided into vertically integrated delivery networks by region, which operate several public and community hospitals, national specialty centers and polyclinics. Financing is delivered through a combination of subsidies, health insurance schemes and health savings plans such as Medisave, Medishield Life and Medifund.

Who conducts HTAs?

The Agency for Care Effectiveness (ACE) is the national HTA agency in Singapore that was established by the MOH in 2015. Its vision is to improve patient outcomes and healthcare value through HTAs, and it aims to drive better clinical and cost-effective patient care decisions. The agency evaluates drugs, devices and medical services using HTA methods from the healthcare system perspective, which aims to maximize health gain from available healthcare resources. These evaluations equip policy makers with objective and credible evidence on clinical efficacy and relative value to determine the technologies that will receive subsidy from the government. ACE conducts HTA decisions in order to support subsidy decision by the respective MOH advisory committee.

What is the HTA process?

Figure 1: Process of HTA evaluation in Singapore

Source: Drug Evaluation Methods and Process Guide, Agency for Care Effectiveness, published in December 2019

The HTA process involves three main steps: topic submission and selection, technical evaluation and decision making.

1. 1. Topic submission: Potential topics for assessments are predominantly identified through applications by public healthcare professionals in Singapore. In addition, new and emerging drugs are identified through literature searches and horizon scanning by the technical team at ACE.
   2. Technical evaluation: Once the topic is selected, evaluations are conducted using either an expedited or full process, depending on the estimated budget impact and the uncertainty around the clinical and cost parameters for each drug. Expedited evaluations usually take 2 to 3 months whereas full evaluations typically take 6 to 9 months. To conduct the evaluation, ACE selects clinical experts to form a Scoping Working Group. A draft scope is then developed. Clinical experts and stakeholders are consulted on the draft scope to ensure the evaluation reflects local clinical practice and addresses the needs of clinicians and patients. Value-based pricing is conducted in parallel with technology evaluations to ensure that the recommended price of the technology represents a cost-effective use of healthcare resources and is commensurate with the technology’s value in Singapore’s context. Manufacturers are invited to submit key clinical information and best prices for their drugs, which then inform ACE’s clinical- and cost-effectiveness analyses and budget-impact assessments.
   3. Decision making: Once the agency completes the final evaluation report, it is presented to the Drug Advisory Committee (DAC) for deliberation. On the basis of the available evidence, the DAC recommends whether a drug should receive subsidy through the Standard Drug List or Medication Assistance Fund. Subsidized drugs are considered the preferred treatment option for producing the best health outcomes while limiting patients’ out-of-pocket expenses. However, drugs which are not currently listed on the SDL are available for patients who can afford to pay for them.
   4. The recommendations are based on four core criteria:
      1. Clinical need of patients and nature of the condition
      2. Clinical-effectiveness and safety of the drug
      3. Cost-effectiveness of the drug
      4. Estimated annual cost of the drug and the number of patients likely to benefit from the technology

How is the process evolving?

Starting in January 2021, pharmaceutical companies will be able to request that their products be evaluated for funding consideration and will be responsible for providing an evidence submission to ACE to support the MOH DAC’s deliberations. For now, only evidence submissions for new cancer treatments (or new indications for existing cancer treatments) will be eligible for evaluation using this route.

Conclusion

HTA will continue to play an important role in the future of Singapore’s healthcare system as it adapts to changing patient needs and improves affordable access to clinically necessary treatments. With the increased participation by manufacturers starting in early 2021, the time between regulatory approval and reimbursement can potentially be shortened giving patients faster access to subsidized lifesaving treatments.

Navigate the regulatory landscape and drive strategic decisions with Clarivate regulatory intelligence solutions.

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The first step in reducing product variation and standardizing vendors is to define a strategy based on industry best practices and internal business intelligence. By pulling data from the organization’s multiple information systems such as EHR and ERP, leaders can gather actionable insights about products being purchased and device spend. Product utilization analysis of both commodity and high-priced physician preference items is necessary if organizations want to reduce or contain costs.

While data is important, it is only useful if a health system has the infrastructure in place to act. An engaged group of stakeholders actively collaborating and responding to a ‘single source of truth’ regarding product selection is the most important factor. Also, vendor standardization and reduced product variation are most effective when built on a patient-centered foundation.

To get insight on best practices and strategies implemented to achieve vendor standardization and reduce product variation, Clarivate recently spoke with Lori Goucher, system clinical value analysis manager at Intermountain Healthcare — a health system in Utah with 23 hospitals, 180 clinics and 2,400 physicians.

Among Ortho Trauma, Cardiac Rhythm Management, Interventional Radiology, and GI Station, in which service area has Intermountain Healthcare standardized its vendors?

We have achieved standardization in some of these areas like Ortho Trauma and Cardiac Rhythm Management. In Ortho Trauma, we were able to standardize this service area to a primary vendor two years ago during contracting. In our experience, contracting is a good time to standardize wherever possible and reduce product variation.

Within Cardiac Rhythm Management, a clinical need strategy helped to focus a primary vendor and identify situations that can fill gaps or indications for use to fill limitations or gaps of service. For effective implementation of standardization, we upgrade our formularies and Doctor Preference Cards — instruments, supplies and equipment required for any surgical procedure — and track compliance and vendor/product performance.

What challenges did you face during vendor standardization, and how were these mitigated?

“The key challenge during standardization is having strong physician preferences for products. To overcome such pushbacks, we have established a robust physician engagement hierarchy as part of our organizational structure.”

To give some background, Intermountain Healthcare had some organizational restructuring three to four years ago. We have since focused on high-value care principles, looking for the highest quality products along with affordability. The key challenge during standardization is navigating strong physician preferences for products. To encourage adoption, we have established a robust physician engagement hierarchy as part of our organizational structure.

At Intermountain Healthcare, we divide our clinical program groups into musculoskeletal, cardiac, general surgery groups and so on. Within these sub-groups, physician representatives work with their peers to bridge product preferences with a focus on empiric evidence for outcomes. It’s a waterfall team structure where specialty groups participate in clinical programs. We strongly encourage our physicians to be involved with their clinical program groups.

What strategies do you use to implement standardization and how do you select the best vendor for any service area?

One way to approach standardization is to be transparent with the physicians and conduct thorough clinical background on different products and performance. At Intermountain Healthcare, we have robust data collection tools that help us with our clinical research as well as to maintain records of how vendor standardization decisions were made in the past.

“One way to approach standardization is to be transparent with the physicians and conduct thorough clinical background on different products and performance.”

While standardizing vendors/products, we also look at patient risk management and out-of-pocket cost for products with new technologies. For instance, recently we had a request for 3D implants. Even though it was approved by our clinical program, when the product came through our formulary it was flagged for research as it required a prior authorization for use. To circumvent such situations going forward, we created a new standard for emerging technologies, such as 3D implants, to have a unique qualifier and prior authorization for medical use, so that the product cost is covered for the patient and they are not surprised by any cost variance.

This blog post is an excerpt of a longer interview. Healthcare Business Insights members have access to a full range of research, tools and insights. To learn more about membership, contact us today.

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Healthcare organizations use various communication methods like social media, blogs and onsite signage to spread awareness about the benefits of COVID-19 vaccines. Social media is especially critical in sharing data on the safety and efficacy of authorized vaccines, which can encourage individuals, including healthcare workers, to get vaccinated.

Current sentiments of social media users and healthcare workers

Clarivate social intelligence experts analyzed user comments on Twitter to understand evolving perspectives on vaccines. They observed a significant shift from September to January, with a rise in the percentage of users eager to take shots. The major findings of the analysis are:

Vaccine skepticism decreases among social media users

Clarivate experts saw negative user sentiment towards getting the vaccine in posts from September to October 2020, highlighting concerns about vaccine safety. However, posts from November 2020 to January 2021 indicates a shift in attitude, with more users sharing positive experiences and their willingness to get vaccinated.

This shift in sentiment may be influenced by several factors, such as the initial data circulated by vaccine developers in early November. Revealing the high efficacy of COVID-19 vaccines, this data may have helped boost public confidence.

Approximately one-sixth of users in the sample analyzed said that they had already received a vaccine and were facing some side effects, the most frequent of which was sore arms.

Most healthcare workers advocate vaccines, some share side effects

The analysis also included social users who identified as healthcare workers. Many of these users shared positive experiences and expressed gratitude towards the researchers who developed vaccines in such a short period of time.

Healthcare workers who have not received vaccines often serve as advocates on Twitter, expressing interest in getting vaccinated as soon as possible to reduce the risk associated with treating COVID-19 patients. Some front-line staff have taken the shots and experienced some side effects, but remain in favor of vaccination.

One user, who identified themself as a nurse working at a hospital, stated:

“I’m 100 percent in support of vaccination!! I received my second Pfizer COVID-19 shot on Saturday as a frontline ED nurse. At hour 8 post-shot I was sleepy and achy. It lasted 24 hours. I promise you’ll feel better by Wednesday!!”

However, 17% of healthcare workers in the sample said they were not in favor of being vaccinated. Reasons for their decline included preexisting medical conditions and concerns about side effects.

Strategies to improve healthcare worker vaccination rates

With nearly one-fifth of healthcare workers continuing to express concerns and hesitancy over receiving COVID-19 vaccines, many healthcare organizations are establishing strategies to address staff concerns and gain their buy-in.

Organizations such as the CDC recommend that healthcare facilities encourage vaccine confidence by incorporating the following strategies:

• Encourage senior leaders to be vaccine champions and share stories on social media, blogs and other channels.
• Communicate frequently with staff and host discussions to address any questions or concerns.
• Share key information and updates on vaccines with staff using internal communication channels such as emails, posters and the organization’s intranet where applicable.
• Educate staff on COVID-19 vaccines and share details on their safety and efficacy.
• Emphasize the importance and benefits of vaccinations and create a feedback mechanism such as a dedicated phone line, internal FAQ or social media livestream to answer staff questions.
• Ensure the visibility of staff receiving vaccinations by developing photo galleries of vaccinated staff or by reaching out to local news outlets.

Along with developing practices to increase staff awareness, several healthcare organizations are offering additional incentives (for example, gift cards or time off) to drive higher vaccination rates among staff.

Communicating the importance of vaccines to healthcare workers is one of the most recommended strategies to drive vaccination rates and reduce hesitancy.

For instance, earlier this year Houston Methodist offered a $500 bonus to all its employees receiving a COVID-19 vaccine to encourage and improve vaccination rates. Similarly, several healthcare facilities are providing gift cards or free breakfasts at certain restaurants to increase the number of staff receiving the COVID-19 vaccines.

Communicating the importance of vaccines to healthcare workers is one of the most recommended strategies to drive vaccination rates and reduce hesitancy. Such strategies can encourage healthcare workers’ confidence in vaccines, which in turn can promote trust among the general population as well.

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Despite pandemic-driven clinical trial delays across multiple therapy areas, novel immuno-oncology approaches continue to advance at a steady pace (see Figure 1), showing promise to support the many unmet needs of cancer patients.

The use of precision medicine, the modulation of the tumor microenvironment and the discovery of potential new actionable targets were amongst the topics covered in the third “EACR – Defence is the Best Attack” conference, which was held as a virtual worldwide event in February.

Here are some of the highlights tracked by the Clarivate immuno-oncology experts at the conference, which provide fascinating insight into the dynamic field of cancer immunotherapy.

Figure 1. Immuno-oncology therapies advance at a steady pace

Source: Cortellis Competitive Intelligence

DNA in the cerebrospinal fluid as a biomarker to evaluate responses to brain cancer

Brain tumors are a prominent exception to the overall robust efficacy of cancer immunotherapy, with only a small fraction of patients responding to checkpoint inhibition. Data obtained from the tumor microenviroment can be used in precision medicine approaches to select the most beneficial treatments and improve patient outcomes. However, due to its location, obtaining representative biopsies from brain tumors is a highly invasive and challenging surgical procedure.

Joan Seoane (VHIO and Mosaic Biomedicals) presented a safer and less-invasive approach using the circulating tumor DNA (ctDNA) found in the cerebrospinal fluid as a liquid biopsy. ctDNA is shed from cells in the tumor, including immune cells in its microenvironment, and then released to the CSF where it can be detected. This approach provides fundamental information about the immune cell landscape, allowing it to make predictions about the potential benefit of immunotherapies, to evaluate patient responses to treatments in real time and to discover potential new targets for drug development.

Myc inhibitors to prevent tumor immune evasion

Sílvia Casacuberta-Serra from Peptomyc presented preclinical data from Omomyc (OMO-103), a cell-penetrating peptide therapeutic that inhibits the oncoprotein Myc, which is deregulated in a wide range of cancers and often associated with highly aggressive tumors.

Myc has been known for a long time as a potential target for anti-cancer therapy, with its inhibition resulting in decreased proliferation and enhanced apoptosis of tumor cells. These new preclinical data showed for the first time that Myc inhibition using Omomyc also interferes with the mechanisms of tumor immune evasion. The therapy reduced tumor burden and increased recruitment and activation of immune cells to the tumor site in a mouse model of non-small cell-lung cancer (NSCLC), the second most common cancer in both men and women. Similar data were observed regardless the driving mutations of the cancer, confirming that the immuno-stimulatory effect is not dependent on the mutational profile of the tumor.

Eosinophils as potential targets to treat breast cancer metastasis

In the majority of cases, breast cancer mortality is the result of tumor metastasis. Sharon Grisaru (Tel Aviv University) focused her presentation on eosinophils, a type of immune cell normally associated with allergic reactions. Recent evidence suggests that these cells are also involved in anti-cancer responses, as hinted by the fact that eosinophils are present in almost 95% of lung cancer metastases from breast cancer patients.

Using a mouse model of breast cancer-derived lung metastasis, the researchers showed that eosinophils are actively recruited to the metastases via a CCR3-independent pathway. They demonstrated their importance in anti-cancer responses, showing an increase in the tumor burden when these cells were depleted.

However, these anti-cancer responses are not performed directly by the eosinophils themselves: eosinophils are first activated by a series of factors in the tumor microenvironment (including IFN-gamma and TNF-alpha), which makes them start secreting CXCL9/10. Cytotoxic CD8+ T cells are then attracted by these signals, and are the ones that directly attack the tumor cells. Altogether these data open the door to a variety of potential new therapies targeting eosinophils in cancer.

Learn more by reading the author’s full report, available to customers of Cortellis Competitive Intelligence.  
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In the U.S., about 30 million people suffer from rare diseases. Lyme disease, rare but considered endemic across much of the Northern hemisphere, is nicknamed the “Great Imitator” based on its ability to mimic other diseases. Globally, since the 1990s, investigators have reported up to a 320% increase in Lyme cases (Johnson 2020, Johnson 2018).

This article presents real-world evidence for the limited usage of current treatment options for Lyme in the U.S., primarily antibiotics and the anti-inflammatory drug Dapsone. Current treatment regimens appear insufficient since the Lyme-causing Borrelia bacteria can undergo genetic mutations, expressing varied surface proteins and multifaceted chronicity and symptom profiles. Due to this ability to mutate, there is an urgent need for precision medicine in the form of single or combination interventions.

Real-world evidence shows high Lyme disease incidence in the U.S.

In the U.S., more than 120,000 new cases of Lyme disease have been detected each year, according to an analysis of Clarivate’s Real World Claims Data Product. All patients with a primary diagnosis of Lyme disease, identified using respective ICD-9 and ICD-10 codes, were included. We entered first record for disease diagnosis in a particular year to ascertain an incident Lyme case and replicated this analysis for each year between 2016 and 2019.

Figure 1. New cases of Lyme disease in the U.S. (2016-2019)

Source: Clarivate’s Real World Claims Data Product

Current treatment options are underutilized

Despite high incidence, our claims-based analysis revealed that antibiotics were only used in 17% of cases between 2016 and 2019, with the highest treatment rate of 19% in 2017. We assessed Lyme treatment using pharmacy and procedure claim records identified using NDC codes, CPT, HCPCS, ICD-9 and ICD-10 procedure codes. We evaluated the use of antibiotics (rifampin, tetracycline, doxycycline) for all diagnosed incident Lyme patients.

Figure 2. Antibiotic use for Lyme disease (2016-2019)
Source: Clarivate’s Real World Claims Data Product

Despite promising efficacy in some studies, Dapsone use not common for Lyme disease

In recent years, there has been a move to repurpose the leprosy drug Dapsone for Lyme disease. Dapsone, also used for tuberculosis, is an anti-inflammatory medication that has shown promising efficacy in some Lyme studies (Horowitz & Freeman, 2019; Horowitz & Freeman, 2018; and Horowitz et al, 2020). Our real world data product analysis did not find frequent use of Dapsone among the diagnosed incident Lyme patients, with proportion of treatment <1% over the period of 2016-2019, inclusive.

How are emerging treatments poised to address the unmet need for Lyme therapy?

As chronic Lyme incidence and complications in patients increase, clinical studies have doubled in the past three years. Current trials are focused on both antibiotics (85%) and vaccine candidates (15%), with about 30% of the studies being conducted in the U.S. (Figures 3-5). However, despite routine antibiotic therapy, a real-world study by Johnson et al reported that only half of the treated patients showed improvements (Johnson 2018).

Figure 3. Country-wide distribution of Lyme studies. A comparison with 2017 data showed that clinical trials have doubled in the last three years.

Source: Cortellis Clinical Trials Intelligence

Figure 4. The University Medical Centre Ljubljana, Pfizer, Valneva Austria and the National Institute of Allergy and Infectious Diseases (NIAID) feature predominantly among the sponsors and collaborators involved globally in Lyme clinical studies

Source: Cortellis Clinical Trials Intelligence

Figure 5. Antibiotics and vaccines under development for Lyme disease

Source: Cortellis Clinical Trials Intelligence

Treatment outcomes may be improved by the use of individualized therapy

While antibiotics remain the standard of care for Lyme patients, data from the MyLymeData registry showed that only 51% of antibiotic-treated cases report some improvement after a year, with 34% classified as high responders to treatment. An alarming 37% of patients complain that their condition was unchanged while 12% reported their condition as worse (Johnson 2018).

Current treatment options for Lyme in the U.S. are underutilized and appear insufficient, as mirrored by our real-world data analysis of Dapsone and antibiotic use. It is unclear whether the low usage of Dapsone is an indicator of the ineffectiveness of this intervention. The Centers for Disease Control and Prevention (CDC) have warned that in the absence of better therapies, up to 1 million new cases of Lyme disease may be reported globally each year.

Our analysis based on data from the Incidence and Prevalence Database, Cortellis Clinical Trials Intelligence and our Real World Data Product highlights the current unmet need for precision medicine in Lyme disease, both in the U.S. and worldwide. At the same time, real-world evidence  and patient registry observational studies can complement randomized controlled trials to determine the optimal approach to generate high treatment response.

A list of therapies with codes is available here.

Download our Trends in clinical trial planning report to access insights from more than 250,000 global trials.

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