IIn the recent uproar over the soaring cost of the EpiPen, you may have missed news that could affect what you pay for autoimmune medications – pharmacy benefits managers for major insurance companies are excluding almost 240 medications from coverage.1 The lists include some frequently-used treatments for autoimmune diseases including rheumatoid arthritis and multiple sclerosis.
But wait, there’s more.
If you decide either the cost or the side effects of medications approved for inflammatory conditions like RA are just too much, Express Scripts, the nation's biggest drug benefits manager, is actually offering refunds to insurers if you quit using the drugs.2
This is part of what Express Scripts calls an “Inflammatory Conditions Care Value Program.” According to the company, this is a “comprehensive approach to control costs and improve care for people with inflammatory conditions like rheumatoid arthritis, psoriasis and Crohn's Disease.” 2
Actually, refunds to insurers are not new, although it may be news to you.
But this is the first time the refunds cover an entire category of drugs, which can only be obtained from a single mail-order company, Acredo.
As part of the plan, participating insurers will be refunded up to $6,000 if a patient discontinues any preferred anti-inflammatory medication within the first 90 days. This new reimbursement approach is “the country's first value-based refund to span multiple preferred medications that treat a group of diseases,” Express Scripts said in a press release.2
An Express Lane for Exclusions
Express Scripts revealed its preferred medications for inflammatory conditions when it issued its preliminary 84-drug exclusion list last month.3
The exclusion list includes a number of biologics such as the injectable tumor necrosis alpha (TNF-α) inhibitor Cimzia (certolizumab pegol) used to treat RA, Crohn’s disease, and psoriatic arthritis, and Taltz (ixekizumab) an interleukin-17 (IL-17) inhibitor newly-approved for moderate to severe plaque psoriasis. 3
Also on the list are:
• Anakinra (kineret) an interleukin-1 receptor antagonist (IL-1ra), excluded only for RA.
• Orencia (abatacept), a selective co-stimulation molecule, which prevents activation of destructive T-cells.
• Simponi (golimumab) a TNF-α inhibitor, 50 mg dose only
• Novolin, Apridra, and NovoLog, insulins for type 1 diabetes. sup>3
Express Scripts’ “preferred alternatives” to these drugs are: Actemra (tocilizumab), Cosentyx (secukinumab), Enbrel (etanercept), Humira (adalimumab), Otezla (apremilast), Remicade (infliximab), Simponi (golimumab) 100 mg, for ulcerative colitis only, Stelara (ustekinumab), Xeljanz (tofacitinib) and Xeljanz XR, and the insulins Humalog and Humulin.2
Under the new “Inflammatory Conditions Care Value Program,” patients must use the mail-order company, Accredo to get their medications. Acredo is billed as Express Scripts "Rheumatoid Arthritis and Inflammatory Disease Therapeutic Resource Center." The center offers some personalized care, which the company says boosts drug adherence.2
Express Scripts claims that between 21% and 36% of patients discontinue their meds within the first 90 days, but adherence is higher with this service. 2 The drugs have an average of $3,036 for a 30-day supply. If you do decide to stop taking one of them, your insurer may get a refund, but you (or your employer, if your benefits come through your job) will still be stuck with the bill.
Actemra (and other medications) may be “reassessed later this year to reflect anticipated product launches,” says Express Scripts. So they could well end up on the exclusion list, too.4
In addition, Express Scripts will now manage the inflammatory drugs formulary category around each individual condition.2 So the same medication could be approved for one autoimmune disease and excluded for another.
Caremark’s New Cuts
As of January 1, 2017 CVS Caremark is excluding 154 medications from its formulary, including three for multiple sclerosis and two for inflammatory bowel disease (IBS).5
The MS drugs are interferon-based treatments, including the widely-used Avonex (interferon beta-1a), the longer-acting Plegridy (peginterferon beta-1a) and Extavia,a copy-cat drug of Betaseron (interferon beta-1b).
Approved alternatives for the excluded MS drugs are Tecfidera, Gilenya (fingolimod), Copaxone (glatiramer), Rebif (interferon beta-a1), Betaseron, and Aubagio (teriflunomide).
The excluded drugs for IBS are Asacol HD and Delzicol (mesalamine). Approved IBS drugs are balasalazide, Apriso (mesalamine extended release caps), Entocort EC (budesonide delayed-release caps), Azulfidine (sulfasalazine) and its extended-release formula, Azulfidine EN-Tabs.
CVS’ has only two approved biologicals -- Enbrel and Humira -- used for a range of inflammatory autoimmune diseases.
It’s important for patients to note that these and other approved autoimmune medications are classified as “specialty medications” and carry restrictions from drug managers.
According to Caremark, medications in this category require “prior authorization” (that means a note from your doctor) and may only be “dispensed in limited quantities.”6 CVS' specialty drugs include the older, conventional DMARD methotrexate along with Enbrel and Humira.6
The exclusion list may well change in 2017, as new medications enter the market, older drugs on the approved list will be re-evaluated, with some medications added back and others excluded, Caremark says.6
Cost-Cutting Helps Insurers – What About Patients?
Together, Express Scripts and CVS Caremark handle pharmacy benefits for more than 200 million Americans.7
Both companies contend that their medication exclusions and care plans are a way to help contain the ever-escalating price of prescription drugs, especially those for inflammatory conditions like RA.7
“Painful inflammatory conditions like rheumatoid arthritis can cripple patients and obliterate payer budgets," said Glen Stettin, MD, Senior Vice President and Chief Innovation Officer at Express Scripts in a statement. "By finding creative ways to take better care of patients and protect our clients' budgets, Express Scripts is uniquely tackling one of the biggest health challenges facing our country today."2
By labeling and excluding select drugs as “hyperinflationary,” Caremark says it is “taking a stand against egregious drug price increases that unnecessarily add costs for clients and their members."6
That may be a bit of hyperbole. “Pharmacy benefits managers can claim to be standing up to pharma on behalf of payers, regardless of the actual dollar or patient impact,” comments the online drug industry economic newsletter Drug Channels.1
Express Scripts says its participating plan sponsors will save approximately $1.8 billion throughout the year through drug exclusions, according to Drug Channels. Caremark claims its formulary exclusions from 2012 to 2017, will save its clients $9 billion.1
But will you save money?
Generally, when drugs are cut from formularies you pay full price for your prescription unless you and your physician accept substitutions or you find a discount program. And some formularies require patients to try older, less expensive DMARDs before they’re allowed to move on to biologicals.
Less than 1% (0.12%) of patients who get their meds from Express Scripts “will be asked to use a different medication that achieves the same health outcome than one they are currently using,” the company says. “If any of these patients have rare clinical needs that require a medication that’s not on the formulary, we have provided a pathway to have that drug covered.”3
MS drug makers were quick to reassure CVS' patients there are mechanisms in place to insure they will have access to their medications.7
Just finding your drug on an exclusion list doesn’t mean you’ll automatically lose coverage. Formularies are only “recommended” and insurers are not required to follow them (of course, plans face higher costs if they do opt out).
Using an approved medication doesn’t automatically mean you’ll save money, either. That depends on your insurance plan’s co-pay. GoodRx medical editor Elizabeth Davis notes that patients may also be able to enlist their doctor’s help to appeal exclusions with their insurance provider.7
If you opt for less expensive brand-name medications or generics, your wallet may take a smaller hit. But prices have been steadily rising for generics, too.
And more drug exclusions are expected from other benefit management companies, reports GoodRx.com, an online service that helps consumers comparison shop for medication prices.7
The cuts do not apply to Medicare plans. If your Medicare coverage is managed by CVS or Express Scripts, check with Medicare.gov or your pharmacist, advises GoodRx.7
Find out all you can about drug exclusions and “care plans.” Investigate manufacturers’ discount programs or coupons. Check whether your state has a Pharmaceutical Assistance Program, which may help you get subsidies or discounts. Shop around for the best prices at GoodRx.com, Discount DrugNetwork.com, EasyDrugCard.com, and similar services.
And, of course, ask your physician whether switching medications is advisable.
1 Fein, AJ. “Seven Takeaways from the New 2017 CVS Health and Express Scripts Formulary Exclusion Lists,” Drug Channels, August 3, 2016. http://www.drugchannels.net/2016/08/seven-takeaways-from-new-2017-cvs.html
2 Express Scripts Launches Inflammatory Conditions Care Value Program(SM), Making America's Costliest Medication Class More Affordable. PR Newswire, September 8, 2016. http://www.prnewswire.com/news-releases/express-scripts-launches-inflammatory-conditions-care-value-programsm-making-americas-costliest-medication-class-more-affordable-300324538.html.
3 Express Scripts, 2017 Preferred Drug List Exclusions. https://www.express-scripts.com/art/pdf/Preferred_Drug_List_Exclusions2017.pdf
4 Express Scripts: 2017 National Preferred Formulary. Aug 1, 2016 http://lab.express-scripts.com/en/lab/insights/drug%20options/2017%20national%20preferred%20formulary.
5 CVS Formulary Drug Removals July 2016. http://www.caremark.com/portal/asset/Formulary_Exclusion_Drug_List.pdf
6 CVS Value Formulary List, Effective July 1, 2016. https://www.caremark.com/portal/asset/Value_Formulary.pdf
7 Davis, E. 40+ Drugs to be Dropped by Insurance. The GoodRx Prescriptions Savings Blog, August 17, 2016. http://www.goodrx.com/blog/40-drugs-to-be-dropped-by-insurance/