Legislative bytes

Another manufacturer takes a WAC at value-based pricing 

On Wednesday, the Institute for Clinical and Economic Review (ICER) announced its founder and president, Steve Pearson, will be transitioning to an advisory role beginning next year. Sarah Emond, formerly ICER’s Executive Vice President and Chief Operating Officer, will transition to ICER’s President and CEO on January 1, 2024, serving as President-Elect in the interim. The organization thanked Dr. Pearson for his vision and leadership in guiding ICER to where it is today, and Dr. Pearson praised his successor, stating that “[I]n spirit and in skill, there is no one more capable than she to take ICER’s vision forward toward a health care system that guarantees affordable and innovative health care to every American.”    

Last Thursday, the FDA announced accelerated approval of Sarepta’s ELEVIDYS (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of pediatric patients with Duchenne muscular dystrophy (DMD). The announcement received significant attention, as the therapy represents a remarkable advancement in treating a disease with urgent unmet medical need and also because it comes with a price tag of $3.2 million. However, Sarepta asserts that its price reflects the value of ELEVIDYS in treating DMD, citing their peer-reviewed publication that conducted cost-effectiveness analyses, finding ELEVIDYS has the potential to be cost-effective at prices ranging from $5 to $13 million when compared to standard of care alone. On a conference call following the announcement, Sarepta’s CEO Doug Ingram said, “Our approach is to ensure that the cost to the healthcare system is less than the potential benefits of ELEVIDYS,” and that the price reflects a “conservative” approach to valuing the therapy’s benefit to patients and their families. 

Sarepta’s decision to focus on value and publish its own cost-effectiveness analyses is reminiscent of Eisai’s similar approach earlier this year when the company announced its wholesale acquisition cost (WAC) for LEQEMBI (lecanemab-irmb), a treatment for mild cognitive impairment and early mild dementia due to Alzheimer’s disease. In January, Eisai issued a press release sharing the quantitative details of its value-based pricing approach, which incorporated the benefits of LEQEMBI to patients, caregivers, and society and provided an alternative value-based price to the one published by ICER. These efforts provide encouraging examples of how manufacturers and other healthcare stakeholders can ensure value is at the center of treatment and pricing decisions. 

If you need assistance with all things value assessment or ICER-related, please contact Kimberly Westrich.

Who’s surprised? 340B drug spending higher for commercially insured patients 

On June 23, JAMA Health Forum published an article on an investigation of the relationship between the 340B Drug Pricing Program and commercial insurance drug spending. The authors studied the association between hospital participation in the 340B program and spending on outpatient-administered oncological drugs for commercially insured patients.

The study contained a cohort of hospitals, including those either new to 340B or that had not participated in the program between 2007 and 2019. Researchers assessed the total drug episode spending for patients receiving common biologics for cancer treatment administered in the outpatient setting at 340B and non-340B hospitals. Researchers used a difference-in-differences model to assess changes in episode drug spending and found new 340B participation between 2010 and 2016 was associated with statistically significantly higher oncological drug-episode spending than hospitals not participating in the program. 

These findings may be attributed to changes in 340B inclusion rules implemented in 2010. Interested parties should recognize drug spending in 340B hospitals will be higher for commercially insured patients and plan accordingly. 

Ready or not, here ICD-11 comes

Earlier this month, the National Committee on Vital and Health Statistics (NCVHS) published a Request for Information (RFI) in the Federal Register seeking public comment on the International Classification of Diseases, 11th Revision (ICD-11) implementation in the US. Comments will help inform discussions ahead of the August 3, 2023, meeting of the Workgroup on Timely and Strategic Action to Inform ICD-11 Policy.

The RFI is seeking public comments on any aspect of ICD-11, but it also includes targeted questions as a guide:
 

What would be the benefits of implementing ICD–11 for morbidity in your setting or organization?	How should HHS implement ICD–11 in the US for morbidity coding?	What kinds of technical resources, guidance, or tools should the US federal government make available?
What information or research will your organization need in order to inform assessments of cost, benefits, implementation approaches, communications, and outreach regarding the transition to ICD-11?	The World Health Organization (WHO) recommends establishing a national center for ICD-11 implementation. What entity should be responsible for coordinating overall national implementation of ICD-11 for morbidity coding, and how should the implementation be managed?	What workforce, workforce planning, or training will your organization need to support implementation?
What considerations affect the impact of ICD-11 on clinical documentation, payment processes (including risk adjustment), public health, population health, or research?	ICD-11 uses an open process in which WHO encourages requests for updates and changes, thus eliminating the main drivers of national clinical modifications. What entity should be responsible for coordinating US requests for updates or changes to ICD-11? How should this process be managed?	What are your organization's requirements for ICD-11 mapping to other coding systems and terminologies, including value sets?
What unique US coding or terminology considerations are essential? For example, coding or terminology related to community health, social determinants of health, essential human needs, sexual orientation, gender identity and expression, obesity, external cause of injury, and information about mental, behavioral, or neurodevelopmental disorders including alignment with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)?	What resources, tools, or support will your organization need for implementation?	What other operational impacts of ICD–11 adoption and implementation should the Department of Health and Human Services (HHS) consider?

Interestingly, at the June committee meeting, NCVHS cited, among other items, the lack of accommodation for the impending ICD-11 updates in their recommendation that HHS not adopt the X12 version 008020 update to the 4 specified transactions (ie, Health Care Claim [Institutional, Professional, and Dental] and the Claim/Remittance Advice).   

The upcoming August meeting will help inform recommendations NCVHS will make to the HHS Secretary regarding US adoption and implementation of ICD-11. To date, the US has not announced transition plans for ICD-11.

Information buffet (AKA, other stuff that caught our attention)