On May 12, 2021, the Institute for Clinical and Economic Review (ICER or the Institute) released plans to begin an annual examination into health insurance drug coverage policies to assess “fair access” to prescription drugs. The purpose of the examination and resulting report is to promote dialogue with regard to whether “insurers are providing appropriate access for drugs that have been responsibly priced.”
The protocols follow a September 2020 white paper analyzing insurance coverage policies and presenting a recommended set of criteria to support transparent discussion regarding “fair” patient access to prescription drugs. The new project is notable because it marks a deepening of ICER’s look at payer policies and how they impact beneficiary access to medications.
Incubated 15 years ago at Harvard Medical School, ICER began attracting much attention in the mid-2010s when it began to publish its value assessment of therapies or classes of therapies to treat specific diseases or conditions. While the Affordable Care Act created the Patient-Centered Outcomes Research Institute (PCORI) and authorized significant funding for PCORI over its early years, the authorizing law limited PCORI’s ability to consider a product’s cost in its analysis.
Enter ICER to fill this void, including by evaluating drugs based on Quality Adjusted Life Years (QALYs) — a metric not commonly used in the United States. As ICER’s work expanded, several of its reports cast a skeptical eye on a number of therapies and even potential therapies. As a result, the Institute has been criticized by the biopharmaceutical sector and by several patient organizations.
The Institute’s decision to look at payer policies that may limit access to care appears to be a signal of its independence and willingness to explore concerns involving both manufacturers and payers. Those who have followed ICER closely will know that the organization has worked productively with a number of patient groups and has issued final assessments that include recommendations that payers abolish or limit the use of certain utilization management tools in certain cases.
In its latest endeavor, ICER plans to examine the coverage policies — including cost sharing, clinical eligibility criteria, prior authorization processes and step therapy protocols — of 15 U.S. commercial payers to determine if they provide fair patient access to 28 commonly used prescription drugs (as assessed by ICER according to a subset of its fair access criteria).
Among others, a number of drugs that are indicated for psoriasis — Cosentyx (secukinumab), Otezla (apremilast), Remicade (infliximab) and Stelara (ustekinumab) — will be examined. Remicade will be examined for both psoriasis and rheumatoid arthritis. ICER also will examine a number of migraine treatments: Aimovig (erenumab), Ajovy (fremanezumab) and Ubrelvy (ubrogepant).
The full list of drugs that will be examined is below:
|Generic Name (Brand Name)||Indication|
|Alemtuzumab (Lemtrada)||Multiple Sclerosis|
|Dupilumab (Dupixent)||Atopic dermatitis|
|Erenumab (Aimovig)||Chronic Migraine|
|Fremanezumab (Ajovy)||Chronic Migraine|
|Onasemnogene Abeparvovec (Zolgensma)||Spinal muscular atrophy|
|Tisagenlecleucel (Kymriah)||Acute lymphoblastic leukemia|
|Infliximab (Remicade)||Psoriasis and Rheumatoid Arthritis|
|Afatinib (Gilotrif)||EGFR Mutationpositive Metastatic Non-Small Cell Lung Cancer|
|Emicizumab (Hemlibra)||Hemophilia A|
|Alirocumab (Praluent)||Heterozygous familial|
|Sacubitril/Valsartan (Entresto)||Congestive heart failure|
|Olaparib (Lynparza)||Ovarian Cancer – Recurrent BRCA Mutated|
|Axicabtagene ciloleucel (Yescarta)||Adult aggressive BCell|
|Plasma-derived C1-INH (Haegarda)||Hereditary Angioedema|
|Gefitinib (Iressa)||Lung cancer – non small-cell|
|Insulin Degludec (Tresiba)||Diabetes|
|Ubrogepant (Ubrelvy)||Acute Migraine|
|Rimegepant (Nurtec)||Acute Migraine|
|Icosapent Ethyl (Vascepa)||Cardiovascular Disease|
|Rivaroxoban (Xarelto)||Cardiovascular Disease|
ICER will be advised by a 14-person “working group” that includes several patient advocates and providers, but only one health insurer and one PBM member (from Harvard Pilgrim Health Care and Prime Therapeutics, respectively). Medicare Advantage and Medicare Prescription Drug Plans and Medicaid managed care plans will not be examined.
ICER’s report is projected to be released in the fall of 2021. Any payer with policies that ICER deems not to meet its fair access criteria will be provided an opportunity to provide comment on the assessment prior to publication. All payers also will be able to submit written comments to be included with any publicly posted materials upon release of the report. As this work plays out, it will be interesting to see if there will be any shifts in how ICER is viewed and if this will be a harbinger of additional examinations focused on payer policies.