Express Scripts Boosts Formulary Exclusions With Focus On Multi-Source Brands

Pharmacy benefit manager adds 64 drugs to its list of formulary exclusions for 2018, bringing to 159 the number designated as not covered.

As pharmacy benefit managers face ongoing criticism over their role in rising prescription drug prices, Express Scripts Holding Co. is touting its decisions to increase the number of drugs excluded from its 2018 national preferred formulary to 159 as a cost saving move.

The change will produce $2.5bn in estimated savings for its payer clients, up from $1.8bn in 2017, the PBM estimates.

The PBM released its national preferred formulary July 31. The formulary is optional for clients but it has been widely adopted. More than 27 million individuals obtain their pharmacy benefit coverage through one of Express Scripts' standard formularies and "more people use the national preferred formulary than any other formulary in the US," the company says.

Express Scripts began to use formulary exclusions began in 2014 to bring more leverage to bear in price negotiations with manufacturers and the list of products excluded has grown every year since then.

By focusing primarily on multi-source brands, Express Scripts can demonstrate a proactive stance on controlling drug costs without causing significant disruption among plan members.

The PBM added 64 drugs to its list of formulary exclusions in 2018 for a total of 159. Most of the newly-excluded products (46) are multi-source drugs with generic competition. (See chart below.) Many of those are in categories that are dominated by generics and have faced generic competition for some time.

"For the first time ever, in 2018, brand drug manufacturers must provide significant savings to be included on the NPF if there are clinically equivalent, lower cost options available," Express Scripts said in a blog on the formulary. For the 2018 NPF, we focused on high-spend multi-source brand drugs."

By focusing primarily on multi-source brands, Express Scripts can demonstrate a proactive stance on controlling drug costs without causing significant disruption among plan members.

"ESI has taken a fairly conservative approach in their 2018 formulary strategy," health benefits consultant Josh Golden, area senior VP with Solid Benefit Guidance, told the Pink Sheet.

"The majority of the new exclusions are for products that have effective generic alternatives, and they’ve avoided any product juggling for the asthma and diabetes classes this time around.  Assuming there are no unexpected curveballs between now and end of year, they should experience a relatively smooth and quiet formulary transition into 2018."  Solid Benefit Guidance is a division of Arthur J. Gallagher.

Also among the newly-excluded products are 18 single-source brands. They include the long-acting opioids Endo Pharmaceuticals Inc.'s Opana ER (oxycodone ER), which the company is withdrawing from the market for safety reasons at FDA's request. (Also see "Curtain Falls On Opana ER As Endo Agrees To US FDA Withdrawal Request" - Pink Sheet, 6 Jul, 2017.) Express Scripts will not cover Depomed Inc.'s transmucosal fentanyl analgesic Lazanda either.

One drug that was excluded from the national preferred formulary in 2017 and will be covered in 2018 (though non-preferred) is Insys Therapeutics Inc.'s Subsys (fentanyl sublingual spray).

Express Scripts will exclude Eli Lilly & Co.'s osteoporosis drug, Forteo (teriparatide) from its formulary in favor of Radius Health Inc.'s Tymlos (abaloparatide), which entered the market in March at a 40% list price discount to the Lilly drug. (See sidebar for related story in our sister publication Scrip.)

Neupogen Excluded For Zarxio But Impact May Be Limited

Another noteworthy change for 2018 is that Amgen Inc.'s neutropenia treatment, Neupogen (filgrastim), will not be covered and follow-ons Granix (tbo-filgrastin), marketed by Teva Pharmaceutical Industries Ltd. and Sandoz Inc.'s Zarxio (filgrastim-sndz) will be covered as preferred alternatives.

The move is a positive signal, Golden notes. "I was pleased to see them come around on Zarxio. Biosimilars will play a critical role in specialty drug pricing over the coming years, so we see this move as a hallmark of an important emerging trend in formulary management."

Though a welcome endorsement, exclusion of Neupogen and preferred coverage for Granix and Zarxio is not likely to have a significant impact because the drugs are generally reimbursed under the medical benefit of insurance plans, not the pharmacy benefit, and so are not subject to extensive management by the PBMs.

Neupogen "is predominantly a physician administered, medical benefit product," an Amgen spokesperson said. "Retail utilization of Neupogen through ESI’s national preferred formulary represents approximately 1.7% of total 2016 U.S. Neupogen sales. … Patients with retail coverage through ESI may still have access to Neupogen via their medical benefit plan."

Epi-Pen Covered But Not Competitors

Mylan Pharmaceuticals Inc.'s emergency allergy treatment, Epi-Pen (epinephrine) will be covered in 2018 as a preferred drug but competing versions of the epinephrine auto-injector marketed by A-S Medication, Impax Laboratories Inc. and Lineage Therapeutics are excluded from coverage.

The PBM has not excluded any new drugs in the diabetes category for 2018; exclusions that were in place in 2017 will remain in effect, a spokesman said. (Also see "CVS Expands Formulary Exclusions In 2017, Express Scripts’ Tally Unchanged" - Pink Sheet, 3 Aug, 2016.)

No changes in coverage for single-source asthma drugs were announced for 2018 and the PBM has continued to avoid excluding multiple sclerosis drugs from its national formulary.

The formulary does not include changes in the hepatitis C or inflammatory drug categories at this point but that may change. "Placement for hepatitis C and treatment for inflammatory conditions are under consideration and changes may occur based upon changes in market dynamics and new products launches," Express Scripts explained. The full list of excluded products will be available on or before Sept. 15.

Express Scripts 2018 National Preferred Formulary: Multi-Source Brand Exclusions
Antipsychotics/Anti-Depressives/Anxiety
Abilify (aripiprazole), Bristol-Myers Squibb, Otsuka	Valium (diazepam), Roche
Effexor XR (venlafaxine), Pfizer	Xanax/XR (alprazolam), Pfizer
Prozac (fluoxetine), Eli Lilly	Zoloft (sertraline), Pfizer
Lexbapro (escitalopram), Forest Labs	Cymbalta (duloxetine), Eli Lilly
Pristiq (desvenlafaxine), Pfizer	Wellbutrin SR (bupropion extended release), GlaxoSmithKline
Seroquel ZR (quetiapine extended release), AstraZeneca	Zoloft (sertraline HCL), Pfizer
Hypertension/Vascular Disease
Benicar/HCT (olmesartan and olmesartan/hydrochlorothiazide, Daiichi Sankyo	Inderal (propranolol), ANI Pharmaceuticals'
Azor (amlopidine, olmesartan medoximil), Daiichi Sankyo	Lovenox (enoxaparin sodium), Sanofi
Tribenzor (amlodipine/olmesartan/hydrochlorathiazide), Diaiichi Sankyo	Plavix (clopidogrel), Brristol-Myers Squibb
Atacand HCT (candesartan celexetil), AstraZeneca	Tikosyn (dofetilide, Pfizer
Allergies/Asthma
Nasonex (mometasone furoate monohydrate), Merck	Singulair (montelukast, Merck
Pulmicort Respules (budesonide inhalation suspension), AstraZeneca	Zyflo CR (zileuton extended release), Chiesi USA
Cholesterol Reducers
Vytorin (ezetimibe and simvastatin), Merck	Merck's Zetia (ezetimibe, Merck
ADHD
Adderall: (dexdtroamphetamine/amphetamine), Shire	Strattera (atomoxetine), Eli Lilly
Intuniv (guafacine), Shire
GERD/Ulcer
Aciphex (rabeprazole sodium), Eisai	Protonix (pantoprazole), Pfizer
Librax (chlordiazepoxide and clidinium), Roche	Zegerid (omeprazole/sodium bicarbonate), Salix Pharmaceuticals
Prevacid (lansoprazole), Takeda
Migraine/headache
Imitrex (sumatriptan succinate), GLaxoSmithKline	Bupap (butalbital and acetaminophen), Valeant
Other
Xenazine (tetrabenazine), Lundbeck, chorea associated with Huntington's Disease	Minastrin (norethindrone acetate and ethynyl estradiol), Allergan, contraceptive
TOBI solution (tobramycin), Novartis, cystic fibrosis	Lunesta (eszopiclone), Sepracor, sleep aid
Plaquenil (hydroxychloroquine sulfate), Sanofi, malaria	Anusol-HC (hydrocortisone), Salix Pharmaceuticals, hemorrhoids
Cytomel (lyothironine sodium), Pfizer, hypothydroidism	Lidoderm (lidocaine), Endo Pharmaceuticals, pain
Valtrex (valacyclovir), GlaxoSmithKline, herpes	Androgel 1% (testosterone), AbbVie, replacement therapy
Source: Express Scripts 2018 National Preferred Formulary