Last fall, ICER released a report titled “The cornerstone of “fair” drug coverage: appropriate drug cost allocation and use management policies. In other words, ICER’s goal is to limit access to medicines when they are deemed cost-effective (for example, cost sharing, coverage restrictions, prescription restrictions, step-by-step treatments). How will they do this? Their Barriers to fair access assessment agreements The method is described. I summarized the following key steps.
- Identify related drugsICER stated that they will list a series of treatments that are considered cost-effective based on the ICER review conducted between 2015 and 2020. They did not specify whether these were assessments started during this period or were completed during this period. Time period, but I will assume the latter.A key point is that ICER’s definition of cost-effectiveness is when the incremental cost-effectiveness ratio of the drug is less than $150,000 per quality-adjusted life year (QALY). or The equivalent life year value (evLYG) is 150,000 USD.
- Update drug pricesAlthough these drugs may be cost-effective when they are launched, rising prices may make the drug no longer of good value. To address this possibility, ICER will update the way prices change over time. Although the prices of many drugs have risen, the rebates paid to PBM have also risen. ICER will use SSR Health’s net price estimate to estimate price changes. ICER will also look at drug price changes based on the wholesale purchase cost (WAC) of the drug and the Federal Supply Planning Service (FSS), especially if there is no data available from SSR Health.
- Final drug listUsing this method, ICER lists 28 drug indication combinations that they believe are of high value.
- View the coverage policies for these high-value drugsICER will then review the underwriting policies of the 15 largest commercial payers to determine whether these drugs have improper access restrictions.
As part of the assessment, what questions will ICER answer? Initially ICER planned to evaluate 20 standards, but as part of this year’s evaluation, they will only evaluate 19 of them. Standards include:
- Unless all drugs are priced above the established fair value threshold, at least one drug in each category should be covered at the lowest level of relevant cost sharing
- If all drugs in a category are priced so that no one drug represents a fair value determined by valuation, then it is reasonable for the payer to place all drugs at a higher cost-sharing level.
- If the pricing of all drugs in a category represents fair value, it is still reasonable for the payer to use priority prescription placement and hierarchical cost allocation to help reduce overall costs.
- The payer should record at least once a year that the clinical eligibility criteria are based on high-quality, up-to-date evidence, and opinions should be provided by clinicians with the same or similar clinical professional experience.
- The clinical eligibility criteria should establish a clear mechanism to require payers to prove that they have: (i) the limitation of evidence due to the systematic underrepresentation of minority groups; (ii) the biological, cultural or social reasons of different communities Whether it is possible to produce unique benefits and harms of treatment, seek the opinions of clinical experts; (iii) Confirm that the clinical eligibility criteria do not exceed the reasonable use of clinical trial inclusion/exclusion criteria to explain or narrow the scope of FDA label language, so as to make it irrelevant to the disease being treated Of potentially disabled patients are at a disadvantage.
- The clinical eligibility criteria that supplement the FDA label language can be used to: (i) diagnostic criteria; and/or (ii) define uncertain clinical terms in the FDA label (for example, “moderate to severe”) and explicitly refer to clinical guidelines or other Standard; and/or (iii) When the payer clearly proves that the triage is reasonable and necessary, triage the patient based on clinical acuity
- Any stepped therapy applied (i) is clinically applicable to all or almost all patients, and does not cause any significant side effects or greater risk of harm, and (ii) if stepped therapy is applied, patients will have a reasonable chance of satisfying them The needs of the first step are the clinical goals of treatment.
- Any required conversion therapy must (i) be based on the same mechanism of action or exhibit risk and side effects characteristics comparable to the index therapy, (ii) have the same route of administration or the difference in the route of administration will not be significant due to clinical or The negative impact of socioeconomic factors on patients, (iii) patients are not required to switch to drugs that they have previously used in a reasonable dose and duration with insufficient response and/or significant side effects, including different payers.
- When the payer clearly confirms one or more of the following reasons, the coverage limits for specialist prescribers are reasonable: (i) Accurate diagnosis and prescription require specialist training, and non-specialist clinicians may feel that they may be harmed or not. Potential patient prescribing drugs in order to benefit, (ii) determining the risks and benefits of individual patient treatment requires expert training, because treatment may have serious side effects, (iii) dosage, side-effect monitoring and overall care coordination require expert training to ensure safety And use drugs effectively.
- When this condition is often treated in primary care facilities, requiring non-specialist clinicians to prove that they are negotiating with relevant specialists is a reasonable option, but certain factors include dosage, side-effect monitoring and/or overall coordination for many patients Of care will benefit from the input of experts.
Many of these assessments require some subjectivity. ICER stated that it will make these decisions by using preliminary judgments made by its internal researchers, which will then be reviewed by ICER staff’s physicians. Nevertheless, the rigor of ICER’s application of these “fair access” standards will be interesting. If it is determined that the underwriting policy will not result in “fair access,” the payer has the ability to provide comments and explanations, and provide written comments when the report is published. Patient representatives will also be able to participate in ICER’s assessment of the fairness of the policy.