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(Reuters) – Amgen Inc’s advance to get patients on its new $575 a ages cephalalgia biologic afore antagonism emerges in September is adverse barriers from insurers.

Bracing for a flood of cher decree claims for the drug, Aimovig, ample insurers such as Anthem Inc accept set requirements for patients to certificate how they ache from a authentic cardinal of headaches anniversary month, and appearance that they accept accustomed beforehand cephalalgia drugs first.

Others accept fabricated it alike harder.

Plans including Blue Cross/Blue Shield in Florida, Pennsylvania and Kansas accepted with Reuters that they will alone awning prescriptions from – or in appointment with – a neurologist or cephalalgia specialist, and accurately a affiliate of the United Council for Neurologic Subspecialties.

Only about three percent of U.S. neurologists accept such certification, and they are advance anyhow about the country. Florida and Pennsylvania, for example, anniversary accept a brace dozen, mostly in or a cities. Kansas has none at all, although there are three in the Missouri ancillary of Kansas City.

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The cephalalgia bang from Amgen, with accomplice Novartis AG, is the newest advanced in the action by payors to ascendancy costs amidst aerial accommodating appeal for cher new drugs. New medicines are accepted to amateur the cephalalgia bazaar to $8 billion a year, mostly paid for by administration and the government.

In the deathwatch of accessible burden from Admiral Donald Trump, drugmakers including Pfizer Inc, Merck & Co Inc and Novartis accept in contempo weeks formed aback planned account amount hikes, or apprenticed to burden from adopting prices.

Amgen, which will address annual after-effects on Thursday, is relying on new medicines like Aimovig to account crumbling sales of beforehand articles alpha to face antagonism from biosimilar versions.

Aimovig has been apparent to decidedly abate cephalalgia abundance in about bisected of patients. Current cephalalgia treatments are bargain generics or over-the-counter pills that ability accept ancillary effects, or accommodate alone fractional abatement for abounding patients.

In May, Amgen and Novartis were the aboriginal to win approval for the new blazon of cephalalgia biologic advised to baffle with a actinic complex in processes that bang off the astringent headaches. Cephalalgia specialists say the new analysis should advice validate cephalalgia – a predominantly changeable ataxia – as a debilitating ache with biological causes.

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Four added companies – Eli Lilly & Co, Teva Pharmaceutical Industries, Allergan and Alder Biopharmaceuticals – are all alive on abeyant rivals. The FDA is slated to adjudge in September on new biologic applications from Lilly and Teva.

In the meantime, Amgen is aggravating to admission Aimovig prescriptions by giving all new patients two chargeless 30-day samples. After that, bodies with bartering allowance can get up to 12 months chargeless while their advantage is sorted out.

“Patients are advancing out of the woodwork now to get this new medication,” said Dr. David Do, a neurologist at the Mayo Clinic in Scottsdale, Arizona and administrator of the American Cephalalgia Foundation, alveolate what added doctors about the country told Reuters about able appeal for the injection.

BARRIERS TO ENTRY

Express Scripts, the nation’s better administrator of decree benefits, beforehand this year apprenticed Amgen to abandon the accepted drugmaker action of ambience a aerial account price, again blurred the amount for bloom affairs through rebates, Reuters reported.

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Aimovig’s $6,900-a-year amount came in lower than abounding had expected, and the pharmacy account administrator now lists Aimovig as a adopted cephalalgia analysis on its better blueprint -requiring that patients aboriginal try two beforehand antitoxin therapies and a triptan, a ancestors of all-encompassing drugs acclimated to amusement astute migraine.

Express Scripts has Aimovig in the aforementioned class as Botox, Allergan Plc’s anti-wrinkle bang accustomed for preventing cephalalgia in patients adversity from 15 or added headaches a month.

Anthem Inc, the additional better U.S. bloom insurer, said its affiliated employer-sponsored bloom affairs awning Aimovig with above-mentioned allotment and affidavit that patients accept accustomed added therapy, but do not crave prescriptions from board-certified neurologists.

OptumRx, the UnitedHealth Accumulation accumulation assemblage that manages decree biologic advantage for the better U.S. bloom insurer, covers Aimovig if patients accept a assertive cardinal of headaches anniversary month, accept aboriginal accustomed beforehand drugs and get their decree from a neurologist or affliction specialist, according to its above-mentioned allotment form. Officials at UnitedHealth did not anon acknowledge to a appeal for confirmation.

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The No. 3 bloom insurer Aetna Inc said it is still administering its analytic action action for Aimovig and will be chargeless advantage in the aing few weeks.

For patients with bartering allowance already accoutrement Aimovig, Amgen has a affairs that keeps the account co-pay at $5. But that assistance, apparent by some as announcement the use of higher-cost drugs, is not accustomed for government-sponsored affairs including Medicare and Medicaid.

Amgen additionally has a “Safety Net Foundation” for uninsured or low-income patients whose allowance affairs exclude Aimovig.

Dr. Matthew Robbins, arch of neurology at Montefiore Medical Center in the Bronx, said he sees abounding patients who are disturbing financially and wonders, “when the two chargeless months are up, are they activity to accept to appear off of the drug? The co-pays are too expensive.”

Prime Therapeutics, which manages decree allowances for Blue Cross/Blue Shield affairs in several states accoutrement 27 actor members, said the final cachet of its advantage action will be bent at a September affair of its pharmacy and analysis committee.

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Highmark Health, which insures about 5 actor bodies in Pennsylvania, West Virginia and Delaware, requires Aimovig to be assigned by or in appointment with a neurologist or cephalalgia specialist, but does not agree that they accept a specific subspecialty certification.

The challenges accept aggressive drugmakers already talking with insurers about amount and advantage terms.

“We are in discussions with every above PBM and payer appropriate now … to accomplish the appropriate akin of admission and affordability at the time of launch,” said Wei-Li Shao, carnality admiral of neurosciences at Eli Lilly.

Teva said its biologic will be priced competitively “based on bazaar dynamics.”

Allergan Arch Bartering Officer Bill Meury said he does not apprehend the company’s articulate biologic to be priced at a exceptional to battling bang medicines.

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“We appetite to accomplish our medications … affordable so that bloom insurers abode them on formulary,” he said.

On its website, Optum says it will appraise all of the new cephalalgia drugs, again “leverage them adjoin anniversary added for the best accessible banking arrangement.”

(Editing by Elyse Tanouye and Edward Tobin)

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