PBMs have used formulary exclusions as an effective way to negotiate with manufacturers for several years. However, at least one payer has gotten more aggressive with its tactics to get members to move from an excluded drug to one with preferred status, dangling a financial incentive for members. That effort is facing pushback from several medical associations, but if it proves to be successful, other companies could follow suit, suggest industry experts.
PBMs began implementing formulary exclusion lists about 10 years ago, and specialty drugs have made up an increasing number of the excluded products. As of early 2021, each of the Big Three — CVS Health’s Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx — was excluding more than 400 products.
Earlier this year, Cigna began offering people on Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) a $500 debit card if they switched from that agent — which moved from preferred to excluded status on Jan. 1 — to one of its preferred inflammatory treatments. Cosentyx is a human interleukin-17A antagonist approved for adult and pediatric plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The company also has a nonpreferred formulary tier.
Then in June, via its Shared Savings Program, the company said it would offer $500 debit cards to people who switch from Remicade (infliximab), from Janssen Biotech, Inc, a Johnson & Johnson company, to a preferred product or one of two of its biosimilars: Amgen Inc.’s Avsola (infliximab-axxq) and Pfizer Inc.’s Inflectra (infliximab-dyyb). On July 1, the company shifted Remicade to nonpreferred status and moved the two biosimilars to preferred status. The change will not impact people taking Remicade for polyarticular juvenile idiopathic arthritis. The debit cards may be used for “health care services and products.”
AIS Health received a copy of the March 10 Cigna letter to providers. It noted that because Cosentyx was no longer on its preferred drug list, patients who remained on that agent were paying a higher copay or coinsurance.
“In an effort to encourage these patients to begin using a preferred brand option,…we will be sending them a letter offering a $500 debit card to make the switch,” reads the letter. “Those who may have already switched are also eligible.”
The letter specified the following as preferred brand options, as noted in Cigna’s 2021 National Preferred Formulary Exclusions in its “Inflammatory Conditions where COSENTYX is indicated” category:
- Eli Lilly and Co.’s Taltz (ixekizumab),
- Amgen’s Enbrel (etanercept) and Otezla (apremilast),
- AbbVie Inc.’s Humira (adalimumab) and Skyrizi (risankizumab-rzaa),
- Janssen’s Stelara SC (ustekinumab) and Tremfya (guselkumab) and
- Pfizer’s Xeljanz (tofacitinib) and Xeljanz XR.
To qualify for the debit card, patients must fill a prescription for a preferred agent at least once before Aug. 1, 2021, and again before Dec. 31, 2021. Then they will receive the card in six to eight weeks following the second fill.
Of the preferred therapies, Taltz — a humanized interleukin-17A antagonist indicated for adult and pediatric plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis — is the only one with the same mechanism of action as Cosentyx.
In a footnote on the exclusion, Cigna explains that “product placement for treatment of Inflammatory Conditions in the Inflammatory Conditions Care Value (ICCV) Program are subject to change throughout the year based upon changes in market dynamics, new indications for existing products, biosimilar and new product launches.” Indeed, in 2020, Taltz was excluded in the inflammatory conditions class, and Cosentyx was a preferred alternative. And in 2019, Cosentyx was a preferred alternative for the inflammatory conditions class.
This therapeutic class has long ranked as the top specialty pharmacy area in terms of pharmacy benefit spend for multiple PBMs. In the 2020 Drug Trend Report from Evernorth — previously from Express Scripts, which became part of that renamed Cigna health services division last year — which was released in March, the inflammatory conditions class again was the top category, with a year-over-year increase of 15.6% in spending, 4.5% in utilization and 11.1% in unit cost.
Cigna did not respond to AIS Health’s questions by press deadline.
Multiple associations are speaking out against the program and encouraging Cigna to discontinue the practice. The American College of Rheumatology (ACR) sent a letter on April 2, noting that “this policy raises serious ethical concerns and we urge Cigna to rescind it immediately.” And an April 16 letter from the American Autoimmune Related Diseases Association, Inc. (AARDA) that was co-signed by 60 other associations asserted that the move undermined providers’ decision making and contended that “targeting patients and enticing them with a financial incentive, particularly during a pandemic — where finances and employment for many are uncertain and patients taking Cosentyx are already experiencing heightened fear of serious illness or death — makes this letter not only unethical, but unconscionable.”
On June 23, the American Medical Association (AMA) passed a resolution developed by the ACR opposing providing financial incentives to switch to a preferred therapy that was spurred by Cigna’s Cosentyx move. Ten additional specialty societies signed on as co-sponsors.
According to the resolution, “Biologic drugs are highly effective and have the potential to reduce long-term disability; however, they are not without certain risks. All classes of biologics used in autoimmune diseases may cause serious adverse events. The decision to choose one biologic over another requires careful clinical evaluation and consideration by a physician and patient. Factors such as an individual patient’s age, gender, diagnosis, medications, specific organ manifestations, antibody status, disease severity, comorbid conditions, and ability to tolerate the route of administration strongly influence the specific biologic choice.”
It notes that patients who switch for nonmedical reasons may be “at risk for significant long-term consequences including irreversible damage and disability. Patients who are switched to another treatment may experience serious disease flares, as even drugs with similar mechanisms of action have widely variable patient to patient effectiveness.” The resolution also maintains that the program “will disproportionately affect patients of lower socio-economic status, who may have less ability to refuse such a payment despite their health interests.”
Following the passage of the resolution, the AMA will “engage with state regulators urging review of the legality of such policies providing financial incentives to patients who switch to preferred drugs.”
“The issue at hand is a third party giving nonmedical advice to patients stable on their treatment to change to a different drug; many of those mentioned were not of the same mechanism of action,” says Brett M. McReynolds, vice president of public policy at AARDA. “From a patient advocacy perspective, the concern comes with what I am seeing as the increased interference in the patient and clinician decision-making from a third party. We want stable patients to be able to stay on the drug their clinician prescribed. Any barriers put in place of this shared decision-making is not helpful — it is harmful.”
“Novartis is committed to putting patients first to ensure there is access to Cosentyx. We are disappointed with Cigna’s actions that could undermine physicians’ ability to make prescribing decisions based on the best clinical interests of their patients and do not consider the clinical and administrative burdens of mandating a switch to a different medicine during a pandemic,” a Novartis spokesperson tells AIS Health, a division of MMIT. He says that the company has not had previous experience with such a program.
“We believe that medicines should be available to all who need them and have a variety of programs that support patients and make it easier for them to access their treatments,” he says. “This includes the Cosentyx Connect Personal Support Program, which can help patients navigate their insurance coverage, secure financial assistance to address out-of-pocket costs if commercially insured and otherwise eligible and obtain free medication for up to two years while a coverage decision is pending.”
He adds that “Cosentyx is backed by robust data derived from more than 14 years of clinical study that demonstrate its safety and efficacy. To date, more than 400,000 patients have been treated with Cosentyx worldwide since its launch in 2015. Cosentyx continues to occupy a unique position as a comprehensive treatment across psoriasis, psoriatic arthritis and axial spondyloarthritis.”
“Insurance companies have inserted themselves into the rheumatologist-patient relationship, and it is dangerous,” maintains Steven Baak, M.D., a rheumatologist and medical director of the Arthritis Center in Bridgeton, Mo. “Most insurance companies do not have an understanding of rheumatology clinical decision making. If they did, they would not make their ‘one-size-fits-all’ policy mandates making their members try and fail more expensive therapies before allowing the rheumatologist doing the actual work to prescribe what is indicated and who takes into account the complex medical conditions that encompass that individual patient.”
He likens the “perverse strategy” to insurers and their PBMs “essentially playing with ‘house money’ like in Las Vegas. The employer is the bank, so there is no way the insurance company will ever ‘lose.’ The PBM wants the employer to think they save them money, but the exact opposite is the reality. Self-funded employers are nothing more than a blank check to a PBM. Rheumatology practices have a giant target on their backs because of the drugs used to treat the conditions we diagnose.”
Baak tells AIS Health that when he conducts a peer-to-peer call with a medical director at an insurer, “nine out of 10 times it is with an OB-GYN or an ER doctor who is reading from a policy script written by an insurance [administrator]. They are not qualified to discuss function, rationale and side effects of biologics in the patient I have known for 25 years who has five chronic medical conditions. Cigna’s latest pay-to-play ‘marketing strategy’ of paying patients $500 to ‘talk’ to their rheumatologist about changing stable patients off Cosentyx to go to Taltz is nothing more than failed negotiations from the Cosentyx manufacturer Novartis that they refused to pay-to-play what Express Scripts, Cigna’s PBM, demanded.…It is all about the money. Follow the money. It always tells the story.”
He says that therapy switches may happen if patients have an allergic reaction to a drug or if it’s not controlling the symptoms or in “situations like planning a pregnancy, lab result indicators, development of other medical conditions, etc. all based on the medical literature and best practices. There is no ‘best practice’ for nonmedical switching.”
“The time, trial, and tweaking of the therapy plans of my complex rheumatology patients is significant, and when the patient and I find a treatment that is working, we simply do not discontinue it. It is not easy on the patient to stop and start therapies, and it is only done after careful consideration of the whole patient,” he says. “These medicines give patients their lives back and allow them to do the things they want to do. Without these medicines, they will go into a flare. This has significant ramifications with missed work, joint damage, ER visits, hospitalization, disability and organ damage.”
Julie Baak, practice manager of the Arthritis Center, says that the letters also are troublesome because patients who have received them have been asking how much of a kickback the providers there are getting from the payer. In addition, she tells AIS Health, “this pay-to-play Express Scripts move influences other PBMs and payers that this is acceptable behavior, which it is not, at least from the perspective of the doctors doing the work. This office has gone to great lengths to separate clinical decision making from insurance company policies so that my staff will prior auth or get covered whatever the doctors deem necessary. Our doctors do not treat patients differently based on payers, and they have no idea which payers’ policies apply to which patients, and I have set it up that way. They prescribe the right medicine and the clinically appropriate therapy plan for that individual patient, and my back-office staff has the task of getting the patient on treatment and navigating the payers’ policies that are not clinically based but rather based on how much money the PBM can make off the backs of the employers and taxpayers.”
OptumRx Has Similar Program
OptumRx implemented a similar program in 2018. Its My ScriptRewards remains active, continuing to focus on HIV medications. Members filling one of the regimens in the program “will receive a $250 prepaid debit card for medical expenses every six months, as long as they continue filling their prescription and the program is available.” The PBM divides drugs into four formulary tiers: Tier 1 for lower-cost generics and some brands, Tier 2 for mid-range preferred brands, Tier 3 for the highest-cost nonpreferred drugs and Tier E for excluded treatments. The HIV therapies in the program are Tier 2, and members receive them at $0 cost share.
The program — which is available to eligible commercial plan members who are covered by group plans — also has added the Convenient Care Cancer Program, which offers members who receive infusions for certain cancer drugs either at home or a preferred facility a “health reward.” The company did not respond to questions on My ScriptRewards by press deadline.
Asked if he has heard of other similar programs, Dea Belazi, president and CEO of AscellaHealth, responds that “Aetna has provided similar programs on the medical benefit for medical procedures, networks or site of service, but I am not aware of other similar targeted drug programs with prepaid debit cards.”
Lynn Nishida, R.Ph., chief pharmacy officer and managing partner at Trend HealthCare Partners, says the two programs are the only incentive programs she’s aware of. “The others that I know of were just small employer groups or plans that offered incentives for joining certain adherence programs or filling out, say, patient surveys, but nothing that I can recall that focused on patient switching.”
Some Incentives Are Not Successful
“Patients have tremendous confidence in the physicians who treat them, and in many cases have a lot of trust in the drugs they prescribe, which can make it challenging to get members to take the actions needed to switch drug therapies even if incentives are offered,” observes Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group (PSG), an EPIC company. “In my experience, incentives offered for site-of-care strategies to redirect patients to lower cost sites for administration of specialty drugs have not been successful; thus, many plan sponsors have opted to [implement] mandatory site-of-care programs instead. Manufacturer-sponsored copay assistance programs which reduce the out-of-pocket spend/cost share for members, often taking their copay or cost share to $0 or $5-$10 for specialty drugs, have been successful as it doesn’t involve any effort from the patients to switch drug therapies. These manufacturer-sponsored copay assistance programs may have some effect on these other incentive programs.”
“This formulary change is disruptive for members, and for those who have experienced positive results or their condition is stable from Cosentyx, they may be less likely to want to switch drug therapies,” she asserts. “This is very different in terms of member impact from asking members to switch their diabetes test strips. Cigna offering a financial incentive allows members the choice to make the switch or not.”
Class Is Crowded, Creating Competition
Rayburg tells AIS Health that “with continued increased trend related to specialty drugs, there is tremendous pressure to find ways to save money, so financial incentives are usually behind a strategy of this magnitude. Contracting efforts with the pharmaceutical manufacturers typically in the form of increased rebates result in these formulary changes. This category of specialty drugs is very crowded, which creates competition among the pharmaceutical manufacturers who are willing to offer increased rebates in exchange for preferred placement to gain increased market share of their products.”
Bill Sullivan, longtime specialty pharmacy industry expert and executive editor of the Anton Rx Report, says that “if I were going to ‘try’ and get ‘proof of concept,’ I would start with a somewhat benign therapy category. Psoriasis fits that mold especially with respect to cost. Inflammatory meds have been tinkered with moving some into more preferred status. Rebates are essential to being selected for preference. Prescribers and patients may be reluctant to move due to ‘ain’t broke…don’t fix it’ mentality. The extra dollars clearly are a means to get the patients to jump.”
Offering people a cash incentive to change therapies “certainly has to be thought out carefully as to which medications to target for a long-term financial win, without sacrificing patient care and outcomes,” Nishida states. “On the other hand, prescribers may not take kindly to this type of outreach or incentive, since they will be the ones having to maneuver patient requests for switches, and in their view if a patient is doing well on therapy, they are not apt to want to change. Therefore, plans/payers need to work collaboratively with the prescribers for patient switches for this type of program or any program that encourages switching or directing patients and their prescribers to preferred options to be truly successful.”
According to Belazi, “consideration should be given to patients who are stable on therapy to be able to continue their medication regimen and avoid unnecessary medical cost expenditures and additional physician monitoring and visits.”
Ira Studin, principal at Stellar Managed Care Consulting, LLC, tells AIS Health that he is not familiar with Cigna’s program, but he says that it “bears emphasizing, however, that the grandfathering is usually for a short period of time — maybe three to six months max. Then, if that agent is excluded, patients have to use the new preferred agent. Their only out is by making a formulary exception appeal, which is a medical-necessity argument the prescriber has to present to justify the patient receiving the original agent. But, percentage-wise, those tend to be pretty limited.”
Is Strategy Prep for Humira Biosimilars?
According to Nishida, “some say that this strategy is a dress rehearsal that can be used when” Humira biosimilars hit the market, which will happen in 2023. “Depending on how the market shakes up in pricing, there could be a significant push to switch patients on Humira to biosimilars, including the use of cash incentives.” As of July 2021, the FDA had approved six biosimilars of Humira, the top-selling drug in the U.S. and worldwide; as of June 1, at least five more were in the pipeline. AbbVie has reached agreements specifying launch dates for eight of the competitors so far, with Amgen’s Amjevita (adalimumab-atto) cleared to launch first, on Jan. 31, 2023.
What makes a biosimilar switching program different from one involving drugs with different mechanisms of action “is that biosimilars are the same drug but made by different manufacturers,” explains Rayburg. “Because biologics are made from or with living materials, exact copies cannot be made, which is why biosimilars are not interchangeable, but all products are infliximab in this [Cigna Shared Savings Program]. Cosentyx and Taltz are in the same family of drugs (IL-17A inhibitors), but they are not the same drug.”
Those latter two drugs are both self-administered via subcutaneous injections, but they differ in the doses that are available and the frequency of the loading doses, she notes. “For new starts to therapy with Taltz for plaque psoriasis as an example, they will have to start with the loading dose, which is two injections at first, followed by one injection every two weeks for 12 weeks, then the maintenance dose every four weeks. They would be switching from their current maintenance dose of Cosentyx, which involves an injection every four weeks.” Plan sponsors would be responsible for “very high up-front costs, often $17,000 or more,” for such loading doses, she adds.
Such a program is likely to be “a key strategy for these plans or PBMs as they try to get switches to happen for biosimilars, which in theory could be a bit more palatable with prescribers (maybe), since biosimilars are presumed to perform similarly to their reference product (e.g., Inflectra vs. Remicade, Amjevita vs. Humira), whereas in the Taltz vs. Cosentyx scenario, you are dealing with two drugs that although are considered to have similar efficacy and safety risks, they are different medications altogether and may vary in their adverse events and how patients uniquely respond,” says Nishida. “These differences could still occur with biosimilar switching, but changing to a different medication is just one additional consideration that is factored in.”
“If these programs show success, more payers may consider” implementing them, says Rayburg. “There has to be a ‘what’s in it for me’ for members to even think about changing medications; however, it is more likely for them to do so if directed by their physicians.”
“If the Cigna and United programs see significant adoption by the prescribing physicians and patients, it is likely that other payers will begin to adopt programs of this type,” agrees Belazi. “These programs would be utilized as another methodology to engage the patients and initiate therapy conversions that would be in alignment with the payer’s preferred product list.”
Potential classes that could be targeted are those with multiple treatment options that have similar efficacy, mechanisms of action and indications such as insulin, growth hormone and hyaluronic acid, he says. Rayburg says the multiple sclerosis class may be another category that payers consider.
“Assuming that the trial balloon continues to fly, the obvious categories will be where there is the big spend and sufficient competition,” says Sullivan, including oncology, inflammatory conditions, multiple sclerosis and HIV. “Actually, one could look at all drugs that have been listed as preferred in the past couple of years that had no ‘better efficacy’ profile.”
Belazi cautions that such programs need to be balanced with the physician-patient relationship. “Financial incentives that may move a patient off of a stable medication therapy regimen to a similar therapy may not be in the overall best interest of managing their disease and may cause other medical costs to escalate.”
‘Payers Need to Think Long Term’
With PBMs switching up formularies often, “this is where payers need to think long term,” Nishida says. “Constant switches in formulary status of medications and thus trying to get patients to switch back/forth then back again is not best practice. Therefore, payers have to be mindful of this and be forecasting out as long as possible to prevent constant formulary changes year after year that can impact the continuity of a patient’s treatment.”
Contact Belazi through Caroline Chambers at email@example.com, Nishida at firstname.lastname@example.org, Rayburg via Samantha Rideout at SRideout@psgconsults.com and Studin at email@example.com.