Improving access to care: Q&A with Upsher-Smith's Rusty Field
Drug Store News caught up with Upsher-Smith chief commercial officer Rusty Field to discuss topiramate extended-release capsules, its new authorized generic to Qudexy XR.
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DSN: In July, Upsher-Smith took the unusual step of launching topiramate extended-release capsules, the authorized version of Qudexy XR, almost immediately after the release of the branded version. President and CEO Mark Evenstad has described the move as a way to get this new anti-epileptic medication into the hands of clinicians and patients faster and more affordably, but please describe what, in your own words, led to the decision.
Rusty Field: The current system of getting medication to patients is very complex, and physician decisions to treat with a certain antiepileptic drug, or AED, do not always translate into the patient getting the drug, due to issues of access and cost. This motivated Upsher-Smith to implement a unique business model designed to improve access to effective treatments and reduce healthcare costs.
One example of this is our immediate introduction of an authorized generic to Qudexy XR. An authorized generic, or AG, is a means for Upsher-Smith to provide widespread and affordable access to our extended-release topiramate. This benefits the patient and the payer.
DSN: Given the generally lower pricing structure for authorized generics, what impact does Upsher-Smith expect the move to have on projected top-line sales and bottom-line profitability for Qudexy XR?
Field: Reducing the cost and supporting enhanced accessibility will, we anticipate, result in higher use and support profitability.
DSN: What do you anticipate will be the main avenues for distribution of topiramate? Can you describe the strategy being employed to market both versions of the drug simultaneously?
Field: When clinicians write Qudexy XR, their patients should typically receive the authorized generic, topiramate extended-release capsules from Upsher-Smith, at the pharmacy. It will be available to many covered patients at a generic co-pay. The authorized generic is available to retail pharmacies nationwide.
DSN: Is Upsher-Smith working with a partner on the distribution and/or manufacturing of the authorized generic, or in-house with its own branded generic and generic division? If so, do you have separate sales forces calling on doctors and/or pharmaceutical retail buyers and wholesalers?
Field: The authorized generic is manufactured and distributed by Upsher-Smith. We let customers know that the authorized generic is manufactured using the same materials and process by the same company. Of course, our brand team is responsible for getting the news out to prescribers, and our generic team is responsible for getting the authorized generic established in the market, including support from our award-winning sales teams.
DSN: Have you had any feedback from the epilepsy community, or from advocacy organizations or government, in response to the company's move to provide immediate access to both versions of the medication?
Field: We have had some very positive early feedback:
Twenty-four hours post launch, a physician asked a representative to lunch in order to hear more about our multifaceted program.
One physician said “I would like to shake your CEO's hand and thank him for trying to positively impact health care.”
DSN: What sets Qudexy XR apart from older antiepileptics? How large is the market for these products in the United States?
Field: Topiramate is a well-known, effective agent for the treatment of a variety of seizure disorders, but many patients experience challenging cognitive side effects while taking the immediate-release formulation of the drug. Upsher-Smith conducted a global phase 3 clinical trial which showed that Qudexy XR, a once-daily extended-release formulation of topiramate, is efficacious across a range of seizure types and patient severity. This extended-release formulation appears to be a new delivery system of a very effective compound. By improving the delivery method, we hope to improve tolerability, which may lead to better seizure control in patients.
Other points of differentiation include:
Qudexy XR and its AG is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It is also approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
All strengths of Qudexy XR and its AG may be swallowed whole or administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of soft food. This makes it the only approved extended-release topiramate product for patients who experience challenges swallowing whole capsules or tablets.
DSN: Is there a competing generic already in the marketplace with 180-day exclusivity?
Field: Beside our own product, there are no other generic equivalents to Qudexy XR on the market.
DSN: Some 200,000 new cases of epilepsy are now diagnosed each year, which indicates a growth rate of roughly 10% each year in cases of the disease. What do you think is driving that increase?
Field: According to the Epilepsy Foundation, children under the age of 2 years and adults over 65 years are more likely to develop epilepsy than any other age group. This is explained in part by changes that occur in the brains of people early and late in life. The rise in the incidence of epilepsy in adults as they age is due to changes in the brain caused by tumors, strokes and other brain abnormalities.