This report originally ran in the Feb. 28, 2020 edition of Politico's Prescription Pulse Newsletter. 

The Institute for Clinical and Economic Review revised its previous assessment of two new migraine drugs, determining that they meet its long-term cost-effectiveness thresholds — after previously ruling the cost of the medicines was too high. The final evidence report concluded that Allergan's Ubrelvy, which costs $4,896 a year, and Biohaven's rimegepant meet the cost-effectiveness threshold.

This article originally appeared in Inside Health Policy on Feb. 27, 2020. 

Policy and patient advocacy groups are calling on the Institute for Clinical and Economic Review to rerun its analysis on the cost-effectiveness of three drugs to treat acute migraines, using ICER’s updated framework that considers societal factors. The advocacy groups expect the cost-effectiveness rating of the three drugs would increase further using that framework.

This article originally appeared in Bloomberg Law on Feb. 26, 2020. 

Lost work days and time spent in emergency rooms should have weighed more heavily in an analysis of migraine medicines by an influential advisory board, advocates said. The Institute for Clinical and Economic Review, a nonprofit that analyzes whether a drug’s outcome for patients justifies its price tag, can sway insurers’ decisions on drug coverage. It recently determined that Allergan’s Ubrelvy, Eli Lilly’s Reyvow, and rimegepant—a Biohaven drug still being considered for approval by the FDA—aren’t superior to older, cheaper drugs already on the market.

​In This Week’s Issue:
 
1. ICER Releases Cystic Fibrosis Draft Evidence Report: Learn More, see details below.
2. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Sickle Cell Disease, click here to read the letter.
3. Washington State Senate Votes to Give Prescription Drug Affordability Board Power to Use Cost Thresholds Without Patient Representation, see details below.
4. Pioneer Institute: ICER's Methods Are Likely Illegal under the ADA, click here to read the report.
5. Massachusetts Finalizes Value Assessment Regulations, see details below.
6. ICER's Oral Semaglutide Model Exists in an Imaginary World, click here to read the article.
7. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more. 
8. ICER's QALY-Based Study Topics: Hemophilia A, Beta Thalassemia, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, click here to provide patient input.
9. Upcoming Events and Webinars, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.  

In This Week’s Issue:
 
1. Pioneer Institute: ICER's Methods Are Likely Illegal under the ADA, click here to read the report.
2. Massachusetts Finalizes Value Assessment Regulations, see details below.
3. ICER's Oral Semaglutide Model Exists in an Imaginary World, click here to read the article.
4. Patients and People with Disabilities Remain Concerned about Importing QALYs From Other Countries, see details below.
5. Administration’s Medicaid Initiative Would Invite Closed Formularies, Implicate Use of QALYs, see details below.
6. A Trusting Relationship is Crucial to Bridge the Gap Between Quality Metrics and Real Life, click here to read the article (subscription needed).
7. ICER Releases Revised Value Assessment Framework for 2020, see details below.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more. 
9. ICER's QALY-Based Study Topics: Hemophilia A, Beta Thalassemia, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.  

In This Week’s Issue:
 
1. PIPC, ALS Association, and Epilepsy Foundation on Massachusetts Approach to Drug Value Assessment, click here to read the press release.
2. Patients and People with Disabilities Remain Concerned about Importing QALYs From Other Countries, see details below.
3. Administration’s Medicaid Initiative Would Invite Closed Formularies, Implicate Use of QALYs, see details below.
4. ICER Releases Revised Value Assessment Framework for 2020, see details below.
5. Webinar on ICER's Sickle Cell Report, click here to view the webinar.
6. Undark: Patients are Rightfully Wary of QALY-based Analyses, click here to read the article.
7. An Independent Federal Agency Recognizes the Danger of QALYs, click here to read the blog post.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more. 
9. ICER's QALY-Based Study Topics: Hemophilia A, Beta Thalassemia, Acute Migraine, Arthritis, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.  

​On February 5, 2020, the Massachusetts Health Policy Commission (HPC) finalized regulations outlining their approach to assessing the value of prescription drugs. As groups representing patients and people with disabilities, the affordability of health care is a significant priority. That being said, HPC’s regulations put patient access at risk, and may ultimately do more harm than good for patients. They set the stage for third-party analyses by groups like the Institute for Clinical and Economic Review (ICER) and rely on international reference pricing, which relies on QALY-based assessments in determining the “value” of treatments. 

In This Week’s Issue:
 
1. Patients and People with Disabilities Remain Concerned about Importing QALYs From Other Countries, see details below.
2. Administration’s Medicaid Initiative Would Invite Closed Formularies, Implicate Use of QALYs, see details below.
3. ICER Releases Revised Value Assessment Framework for 2020, see details below.
4. Webinar on ICER's Sickle Cell Report, click here to view the webinar.
5. Undark: Patients are Rightfully Wary of QALY-based Analyses, click here to read the article.
6. Colorado is Next to Propose Use of the Discriminatory QALY Method to Restrict Coverage, see details below.
7. An Independent Federal Agency Recognizes the Danger of QALYs, click here to read the blog post.
8. New National Health Council Patient Engagement Tool, click here to read more.
9. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more. 
10. ICER's QALY-Based Study Topics: Hemophilia A, Beta Thalassemia, Acute Migraine, Arthritis, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.  

​On Jan. 31, the Institute for Clinical and Economic Review (ICER) released its final revisions to its value assessment framework. The document describes changes in ICER’s process, including creating a formal process for incorporating new evidence that emerges after the assessment, standardizing cost-effectiveness thresholds across reviews, and increasing the incorporation of real-world evidence.

Is the life of a person with a disability or chronic condition less valuable than the life of a person without one? There is renewed interest among lawmakers to tackle healthcare costs, specifically, the rising cost of prescription drugs. However, the Administration’s proposed International Pricing Index (IPI) model, an initiative proposed in 2018 that would arbitrarily base prices of American medications off the government set prices of medications in foreign countries, is deeply flawed. Yet, we may see some version of it reintroduced soon.