Novo Nordisk Lays Out Obesity Commercial Strategy, Ahead of Liraglutide FDA Submission

Reimbursement and sales strategy for liraglutide 3 mg to treat obesity, which the pharma hopes to launch in 2015, are a focus as the pharma laid out its long-term plans in an analyst meeting on Dec. 3. It suggested payers, who aren’t embracing new obesity drugs, could try patients on the drug for a trial period and proceed only with the best responders.

Novo Nordisk AS has resembled big biotechs more than its pharma peers in the last decade, with phenomenal sales growth and share price gains. Diabetes has predominately driven that climb; diabetes care sales accounted for 78% of the pharma’s total sales in the first nine months of 2013. Now it is readying itself to branch out into obesity – with an anticipated FDA review and launch of liraglutide as an obesity treatment.

At an investor day on Dec. 3, Novo Nordisk laid out its commercial plans in obesity and detailed how it plans to use its global presence as the diabetes sales leader to move into obesity. The company that gaining a commercial foothold has been no easy task for the two recently approved obesity drugs. But the pharma expects that its established diabetes foothold will enable it to more easily reach physicians likely to prescribe an obesity drug and patients who would be more willing to use an already proven therapeutic to treat obesity and its associated complications.

The company confirmed that it expects to submit for FDA approval before year end for obesity treatment liraglutide 3 mg. Liraglutide is already marketed as type II diabetes treatment Victoza, which is administered by subcutaneous injection of 0.6 mg up to 1.8 mg. Liraglutide to treat obesity would also be a subcutaneous injection, but of 3 mg daily, a dosage that has proven effective in clinical trials for weight loss (Also see "Novo Is On Track To File Liraglutide For Obesity By 2014" - Pink Sheet, 8 Aug, 2013.).

Demonstrating efficacy and safety to FDA for obesity drugs has long been an industry stumbling block, but Novo Nordisk seems confident on this front, particularly since a lower dose of liraglutide is already in use. If approved by FDA, the company said it’s anticipating a 2015 launch for liraglutide as an obesity treatment.

Reimbursement A Rarity

An FDA approval, however, even paired with an ever-growing obese population, does not a market make. Of the roughly 700,000 U.S. patients taking a drug to treat obesity, the vast majority are on generic phentermine. Qsymia (phentermine/topiramate ER) from Vivus Inc. and Belviq (lorcaserin) from Eisai Inc. and Arena Pharmaceuticals Inc. have barely made a dent in sales.

Another obesity candidate, Contrave (naltrexone SR/bupropion SR) from Orexigen Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd., is expected to be on the market in 2014 in U.S. and Europe, if approved (Also see "Orexigen Hopes FDA Sees The LIGHT On Contrave NDA" - Pink Sheet, 25 Nov, 2013.).

The challenge that these companies face, which Novo Nordisk will also have, is reimbursement. Although the American Medical Association declared obesity a disease state in June, Novo Nordisk noted that only about 43% of Americans with medication insurance coverage have obesity therapeutics covered under their plan – and those are typically in Tier 3, which have usage restrictions and high co-pays. For the remaining 57%, obesity drugs are not covered at all.

That’s a fundamental problem because few patients are willing to pay for the new obesity drugs entirely out-of-pocket. The proportion of patients paying cash for Qsymia was 13% and for Belviq was 14%, according to IMS data from September that Novo Nordisk presented.

“So, it is important to establish an agreement with the payers on reimbursement of a product to make it successful in the obesity space in the U.S.,” concluded Jakob Riis, Novo Nordisk EVP of marketing and medical affairs.

Novo Nordisk aims to target only about 5% of the 107 million obese Americans with co-morbidities such as coronary artery disease, hypertension and back pain. It’s aiming for patients with a body mass index over 35 with co-morbidities, who have previously tried prescription medication for obesity. But that’s still more than 5 million U.S. patients; currently there are only about 750,000 patients on Victoza globally and it had about $1.5 billion in sales in the first nine months of 2013.

No Cure, No Pay

Importantly, payers may be able to identify patients who would most benefit from the product, thereby potentially providing them means to sort out reimbursement issues down the road. Based on clinical trial results, the pharma said it can accurately predict the one-year weight loss curve of a patient based on how successful they were in the first three months. For example, if a patient has a 4% weight loss in the first three months they can predict with a “very high degree of certainty” that their full-year weight loss will be about 11%, said Novo Nordisk EVP and CSO Mads Krogsgaard Thomsen.

So, payers may be able to sort out longer-term reimbursement on a “no cure, no pay” basis, suggested Novo Nordisk SVP and CMO Alan Moses. That could allow payers to make treatment cheaper and more accessible to obese patients, but only to continue reimbursement beyond a three-month period if a patient’s biology and behavior are sufficiently responsive.

“It’s not a very costly experiment to do,” said Moses. “You give patients the opportunity to try it out for three months and to combine both liraglutide 3 mg and the behavior change and then you take a read from that.”

Liraglutide is intended to be used in addition to lifestyle changes such as improved diet and exercise. There are 3,731 patients in the SCALE program, those receiving liraglutide 3 mg for 56 weeks showed an 8% average weight loss, with the placebo group having an average of 2.6%. Various sub-segments of the program focus on co-morbidities such as sleep apnea and diabetes.

For pre-diabetic patients, payers may view intervention as crucial; patients with a diabetic diagnosis have an average annual cost of about $13,000, Novo Nordisk said. Pre-diabetic patients show impaired glucose control in a fasting blood glucose test. About two-thirds of the patients in its SCALE Phase III program for liraglutide 3mg were pre-diabetic. “They will be a large proportion of the patients we will target. And, depending on the extension of the trial, you can see some of the claims will be around from pre-diabetes to diabetes or from not having anything into pre-diabetes,” said Riis.

He cautioned that encouraging existing Victoza patients to transition to liraglutide 3 mg would not be a part of the company’s marketing strategy – noting that there are less than half a million Victoza patients in the U.S.

On the prescriber side, Novo Nordisk initially plans to target physicians who are high-prescribers of obesity medications as well as those who are already high-prescribers of the GLP-1 (glucagon-like peptide-1 receptor agonist) class, of which liraglutide is a member. The company anticipates that these two groups would mean reaching out to about 20,000 U.S. physicians; it already reaches about 130,000 physicians in the U.S. It expects to use its existing sales force to market liraglutide to treat obesity.

So, Moses concluded, “We can basically cover the very relevant prescriber base in the obesity space with almost a quarter of the U.S. sales force.” Eisai recently said it would increase its targeted U.S. physicians for Belviq to 65,000 from the previous field of 10,000 (Also see "With Another Push From Eisai, Can Arena’s Belviq Be A Blockbuster?" - Pink Sheet, 11 Nov, 2013.). Novo Nordisk said this sales plan is a starting point and that it will expand upon it if liraglutide 3 mg proves successful.