Drug Trends to Watch, Actions to Consider
by Robert Kordella, RPh, MBA
Senior Vice President and Chief Clinical Officer
Rising prescription costs related to the treatment of diabetes are being driven primarily by increases in utilization, and secondarily by increases in unit cost. The American Diabetes Association (ADA) revised its treatment guidelines to remove the recommendation that drugs in the GLP-1 agonist category (e.g. Ozempic, Trulicity, Rybelsus, etc.) and in the SGLT-2 inhibitor category (e.g. Jardiance, Farxiga, Invokana) be restricted for use in Type 2 diabetes patients who had first tried and failed a course of an inexpensive version of metformin. This change effectively established both categories as first-line treatments for newly-diagnosed Type 2 diabetes patients.
In addition, two drugs that are also GLP agonists (Wegovy & Saxenda), that are uniquely approved for use in managing overweight and obese patients, but are not approved for use in treating diabetes, are also experiencing tremendous increases in both utilization and incremental cost, both for plans that do and do not cover weight loss medications. Some plans that do cover weight loss medications, even with clinically reasonable utilization management in full conformance to their respective FDA-labeled indications controls, have seen Wegovy and Saxenda rapidly climb into their top ten most expensive therapeutic categories. More problematic, for plans that do not wish to cover weight loss medications, the surreptitious use of Ozempic, Trulicity, Rybelsus, etc. for weight loss and not for diabetes (driven primarily by social media and the press) have added to costs where controls are not sufficiently tight. The extent of this surreptitious use is of such high magnitude that diabetes patients have suffered supply shortages that have disrupted access to their diabetes treatments.
To best way to inhibit the surreptitious use of Ozempic, Trulicity, Rybelsus, etc. for weight loss is to ask your PBM or Carrier to implement a utilization management control for all patients new to Ozempic, Trulicity, Rybelsus, etc. that requires documentation (and not mere physician attestation) of a hemoglobin A1c value greater than 6.4%, which meets the clinical definition of diabetes. PBMs and Carriers may respond that such a control might impact your existing rebate guarantee, but if they do, please contact us for assistance in resolving that issue.
Rising prescriptions costs related to migraine treatment and prevention are primarily being driven by increases in utilization and secondarily by increases in unit cost as newer high-cost biologic medications crowd out older, less expensive products.
One of the underlying changes in migraine management is the development of preventive medications that effectively reduce the number of migraine attacks per month. The best way for a plan to manage migraine management costs is to work with us and your PBM or carrier to identify which migraine patients in a population are more cost-effectively managed through the chronic use of preventive medications vs. those whose migraine attacks are either less severe and/or less frequent who can be managed more cost-effectively by using older, less expensive medications. Please contact us to facilitate that discussion with your PBM or Carrier.
BIOLOGIC ANTI-INFLAMMATORY DRUGS
Several cost, utilization, and market dynamic drivers are leading to increasing trends in the biologic, anti-inflammatory (BAI) category that includes drugs such as Humira, Stelara, Rinvoq, Skyrizi, Dupixent, and Cosentyx, for example. It is difficult to ignore the onslaught of consumer advertising encouraging patients to “Ask your doctor” about one of the many indications these medications are used to treat (for example, rheumatoid arthritis, psoriasis, Crohn’s disease, ulcerative colitis, atopic dermatitis, and asthma, among others).
The best way for a plan to manage costs of these drugs (which are often the most expensive in any plan) is to: a) ensure the existence of FDA label-conforming utilization management controls, b) ensure that prior authorization time limits do not exceed one year, and c) that Days’ Supply limitations do not exceed 30 days. We have done much work in this area and are happy to assist in tightening up clinical controls where needed.
Finally, the end of June, 2023 will likely see the FDA approve a new gene therapy (named Roctavian, one-time infusion cost expected to be ~$2.5 million) for the treatment of hemophilia A. Recall that late last year the FDA approved a new gene therapy for hemophilia B named Hemgenix, and that hemophilia B accounts for roughly 20% of all hemophilia cases while hemophilia A accounts for the remaining 80%. The best way for a plan to prepare for the impending approval of Roctavian is to determine the number of hemophilia A patients over the age of 18 with severe hemophilia A (typically around 60% of hemophilia A patients have severe disease) in your population. We can assist you in preparing for this upcoming addition to the list of high-cost gene therapies that could be suitable for up to 15,000 patients in the U.S.
Robert Kordella, RPh, MBA
Senior Vice President and Chief Clinical Officer
Bob has more than 35 years of diverse experience in the pharmacy industry. Over the course of his career, Bob has led clinical and PBM operations teams in successfully managing more than $4 billion in annual drug spend. This was also while limiting per-member-per-year spending growth to levels that have simultaneously drawn industry acclaim and consistently high levels of member and payer satisfaction.
Amazon Introduces RxPass to Prime Members
By Ferrin Williams, PharmD, MBA
Vice President and Pharmacy Consultant
Amazon has launched a new pharmacy program to help consumers obtain prescription drugs for an additional $5 per month.
The fee covers all medications on their Amazon RxPass medication list, and is added to the $14.99 per month subscription fee for Prime membership. Patients can obtain any quantity of medications (by prescription) that are on the list with no additional out-of-pocket costs. The current list, as of January 2023, has over fifty generic medications.
IMPORTANT THINGS TO KNOW ABOUT RXPASS:
- Patient must be a Prime Member in order to enroll in the program.
- This program is business-to-consumer and is not part of an employer’s benefit. The prescriptions are processed outside of the patient’s insurance and therefore do not apply towards deductibles or out-of-pocket maximums.
- RxPass is not currently available to Medicaid or Medicare members.
- These prescriptions are not eligible for COB, HAS, or FSA.
- RxPass is not available in California, Louisiana, Maryland, Minnesota, New Hampshire, Pennsylvania, Texas, and Washington.
- Some of these medications are preventative medications that are often no cost or low cost to members in many employer plans.
RxPass is a nice addition to the Amazon Pharmacy portfolio of programs that includes being an in-network pharmacy option in various PBM networks, as well as Amazon’s Prime Rx Savings card (similar to GoodRx) that can be used at more than 60K pharmacies to obtain discounted prescriptions when not using insurance.
IS RXPASS THE SOLUTION TO RISING PHARMACY COSTS?
The short answer is no. Rising pharmacy costs are being driven by high-cost specialty drugs, not inexpensive generic medications. Generic drugs account for less than 15% of most plan sponsors’ prescription costs.
For our Excelsior Solutions clients, this is another business-to-consumer pharmacy program intended to help consumers obtain low-cost generic drugs. Please contact your Excelsior Solutions pharmacy consultant to discuss this program if you have any questions.
Ferrin Williams, PharmD, MBA
Vice President and Pharmacy Consultant
Ferrin Williams is a pharmacy benefits consultant with over a decade of experience in providing large employers with strategies and advice on lowering their healthcare costs while improving employee health outcomes. Ferrin is a change agent and operations strategist with an in-depth understanding of healthcare administration across the entire PBM spectrum. She is recognized by peers and colleagues as an inspirational leader dedicated to nurturing rising talent and building diverse, cross-functional teams driven by performance, quality, and transparency.
The Pendulum Swing of Copay Coupon Programs
By Shavsha Davis, MS, MPH
The evolution of copay coupon programs is reminiscent of a pendulum swinging from left to right, between manufacturers and PBMs. Each side has had a slight advantage, for a short period time, before the momentum shifts to the other side. Understanding this pattern can help plan sponsors predict when change is coming and make plan decisions to adjust accordingly.
Like any pendulum, there’s a hard left and hard right. The advantage began on the side of the manufacturers. As the price of specialty and brand drugs continued to rise, drug manufacturers designed a way to reduce the out-of-pocket costs for patients by offering copay cards and other copay assistance programs. These incentives adversely impacted commercial insurers two-fold, by promoting more expensive prescription utilization and allowing member out-of-pocket expenses to be met earlier in the plan year. Initially, PBMs were unable to provide an adequate solution for the increase in plan sponsor’s cost because they struggled to identify and track utilization of copay cards.
The momentum shifted towards PBMs, when it was discovered that PBM-owned specialty pharmacies could be leveraged to identify copay card use and adjust accumulators to only apply the true amount of out-of-pocket costs spent by the members.
The force continued to build in the PBMs favor when variable copay card programs were designed to maximize the value of manufacturer copay assistance and reduce costs for both the member and the plan sponsor. In response to these changes, manufacturers have threatened to stop or significantly reduce the value of the copay cards and other copay assistance.
Recent updates from a couple of manufacturers are indicating a swing back to the manufacturers. AbbVie and Janssen announced significant changes to the Terms and Conditions of their copay assistance programs. These changes are anticipated to have a negative impact to the associated plan value for copay maximizer programs. Specialty drugs like Humira, Skyrizi, Rinvoq, Xeljanz, Stelara, Tremfya, and Simponi are being targeted for removal or reduction from various programs. PBMs have taken different stances on how these announced changes may impact their administration of specialty copay assistance programs.
As plan sponsors have used these programs to offset their increasing spend in specialty drugs, it is natural to want the pendulum to remain with the PBM, but it’s logically impossible. With the proper mindset, plan sponsors can learn to embrace the pendulum – and not view it as a diabolical duality. As the landscape of specialty medications continues to change and biosimilars for certain specialty medications emerge, the pharmacy industry will have to evolve to manage costs and promote cost-effective prescribing practices. Excelsior Solutions pharmacy consultants have the expertise necessary to assist plan sponsors in understanding the pharmacy dynamics and developing strategies that align with their goals while making educated and informed decisions.
Shavsha Davis, MS, MPH
Shavsha Davis is a Vice President and Team Lead at Excelsior Solutions with over 20 years of experience in the health care industry. She joined the company in July 2019, specializing in pharmacy consulting. She leads a pharmacy team, which analyzes plan performance, provides financial projections, and interprets marketplace trends for employer plan clients. Her specialty is in designing clinical strategies, negotiating financial improvements, validating, and reconciling pharmacy contract terms.