As Anti-NGF Therapies Resume Phase III Trials, What Attributes of Emerging Therapies Will Most Influence Physician and Payer Decisions?

Osteoarthritis (OA) is a tremendously prevalent condition, affecting more than 70 million individuals in the major pharmaceutical markets, and one of its key characteristics is joint pain. Sales of therapies for the treatment of OA pain comprise the second largest segment of the chronic pain market. Despite the size of the market, however, a truly novel therapy has not emerged for this indication in more than a decade. Because nonsteroidal anti-inflammatory drugs (NSAIDs) and opioid analgesics are the predominant therapies used to manage OA pain, a significant amount of unmet need remains for therapies that lack the severe gastrointestinal, cardiovascular, and/or abuse risks associated with these current standards of care. Only one emerging class of agents—monoclonal antibodies against nerve growth factor (anti-NGFs)—has demonstrated the potential to improve on the efficacy, safety, and tolerability problems that plague the current therapies used to treat OA pain. However, the commercial success of the anti-NGFs in OA pain will ultimately hinge on overcoming the safety concerns unique to this class of agents as well as any hurdles to accessibility in an overwhelmingly genericized market.

Questions Answered in This Report:

  • Reduction in pain intensity and improvement in physical function are key goals in the treatment of OA pain. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do surveyed U.S. and European rheumatologists weight specific efficacy end points and other drug attributes in their prescribing decisions for OA pain?

  • Celecoxib (Pfizer’s Celebrex, generics) was the 2013 major-market sales leader for OA pain. 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 rheumatologists indicate are most important in their prescribing decisions? Which emerging therapies, if any, will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  • The percentage of patients suffering from gastrointestinal side effects and price per treated day are key drivers of physicians’ prescribing decisions for new OA pain therapies. What trade-offs across these and other clinical attributes are U.S. rheumatologists willing to make when considering the use of emerging therapies for the treatment of OA pain? Based on the trade-offs in price and performance across key drug attributes that U.S. rheumatologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for OA pain?

  • In 2018, Pfizer’s tanezumab will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is tanezumab most differentiated from its competitors? What are rheumatologists’ opinions on the drug’s risk/benefit ratio in the treatment of OA pain?

Scope:

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

- Mean reduction in pain intensity as measured by 100 mm Visual Analogue Scale (VAS) at 12 weeks

- Mean reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at 12 weeks

- Mean reduction in WOMAC total score (pain, stiffness, physical function) at 12 weeks

- Percentage of patients experiencing gastrointestinal side effects during treatment

- Severity of drug interactions and contraindications

- Controlled substance restrictions imposed on manufacture, distribution, and prescription

- Price per treated day

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

- Effect on reducing pain intensity

- Effect on physical functioning

- Rate of serious adverse events

- Controlled substance classification

Physicians surveyed: 60 U.S. and 31 European rheumatologists

Payers surveyed: 21 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Celecoxib (Pfizer’s Celebrex, generics)

- Hydrocodone/acetaminophen (AbbVie’s Vicodin, Vicodin ES, Vicodin HP, various generics)

- Meloxicam (Boehringer Ingelheim’s Mobic, generics)

- Naproxen (various brands and generics)

- Tramadol (available in immediate release [Janssen’s Ultram, other brands and generics], controlled release [Janssen’s Ultram ER, Grünenthal’s Tramal/Contramal/Adolonta, Meda’s Zamadol, generics], and in combination with acetaminophen [Janssen’s ’s Ultracet, Janssen-Cilag’s Tramacet/Tramcet, other brands and generics])

Emerging Therapies

- Tanezumab (Pfizer/Eli Lilly)

- Fulranumab (Johnson & Johnson/Takeda Pharmaceutical)

- BEMA buprenorphine (Endo Pharmaceuticals/BioDelivery Sciences International’s Belbuca)

- Hydrocodone ER (Purdue Pharma’s Hysingla ER)

- Low-dose meloxicam (Iroko Pharmaceuticals)


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