Amid Significant Unmet Need, What Magnitude of Efficacy and Safety Do Endocrinologists and Payers Expect of New and Emerging Therapies?

The evidence demonstrating the serious physical, economic, and societal effects of obesity is growing, and it has resulted in more-concerted efforts to confront this important public health issue. Lifestyle modifications, such as diet and exercise, are the cornerstone of obesity management but have limited efficacy. Bariatric surgery is by far the most effective treatment for obesity, but historically it has been restricted to severely obese patients. Pharmacotherapy aims to provide additional weight loss for patients for whom diet and exercise is insufficient or for whom surgery is not suitable or affordable. Unfortunately, the body’s innate predisposition to retain adipose tissue makes weight loss through pharmacological intervention very challenging. Moreover, several high-profile withdrawals of marketed antiobesity agents have occurred owing to serious adverse events. There is a significant market opportunity for novel prescription weight-loss agents, due to the scope of the epidemic. However, physician and regulatory caution has limited growth in the major markets we cover (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), and the reimbursement environment for antiobesity agent remains challenging. This report aims to identify what physicians and payers are looking for in new prescription weight-loss agents and aims to better define the unmet needs relating to pharmacotherapy for obesity.

Questions Answered in This Report:

  • Obesity is a major public health concern in the United States and Europe, but medical treatment options are limited and effective new agents are urgently needed. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European primary care physicians (PCPs) weight specific efficacy end points and other drug attributes in their prescribing decisions for obesity?

  • Orlistat (Roche’s Xenical, generics) was the 2013 major-market sales leader for obesity. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated potential on the attributes that surveyed endocrinologists indicated are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed managed care organization pharmacy directors (MCO PDs) seek from new therapies?

  • Effect on body weight and price of a therapy are important influences on physicians’ prescribing decisions and payers’ reimbursement coverage. What trade-offs across these and other clinical attributes are physicians and payers willing to make when considering emerging therapies for the treatment of obesity? How do physician preference and prescribing likelihood vary across different target product profiles for obesity? How do drug attributes affect payers’ decisions regarding cost-control restrictions?

  • Based on its clinical profile, phentermine/topiramate ER (Vivus’s Qsymia) is the current clinical gold standard in our Drug Comparator Model, although the available treatments are closely matched overall. What attributes do interviewed thought leaders believe differentiate this therapy from its competitors? Will any therapies in development challenge phentermine/topiramate as the future gold standard?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for obesity:

- Effect on body weight at 1 year

- Effect on body weight at 2 years

- Effect on % of patients with ? 10% weight loss at 1 year

- Effect on glycated hemoglobin (HbA1c) levels

- Effect on annualized incidence of depression/mood disorders

- Treatment/delivery burden

- Price per treated day

Attributes included in assessment of U.S. payers’ receptivity to new therapies for obesity:

- Effect on absolute weight loss

- Effect on categorical weight loss

- Effect on HbA1c level

- Annualized incidence of depression/mood disorders

Physicians surveyed: 61 U.S. and 30 European endocrinologists

Payers surveyed: 21 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Orlistat (Roche’s Xenical)

- Phentermine (Teva Pharmaceuticals’ Adipex-P, Akrimax Pharmaceuticals’ Suprenza, generics)

- Phentermine/topiramate extended-release (ER) topiramate (Vivus’s Qsymia)

- Lorcaserin (Arena Pharmaceuticals/Eisai’s Belviq)

Emerging Therapies

- Naltrexone SR/bupropion SR (Orexigen/Takeda Pharmaceuticals’ Contrave/Mysimba)

- Liraglutide 3 mg (Novo Nordisk’s Saxenda)

- Beloranib (Zafgen)

- Canagliflozin (Janssen Pharmaceuticals [Johnson & Johnson]/Mitsubishi Tanabe Pharma’s Invokana)