The US market-based price for Zurzuvae is worth it

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Our Center for Pharmacoeconomics (CPE) Exclusive suggests Zurzuvae’s estimated benefits for postpartum depression justify its cost even at US market-based pricing over the exclusivity period.

Our most recent CPE Exclusive evaluates the societal impact of Zurzuvae^® (zuranolone; developed and commercialized by Sage Therapeutics, Inc. and Biogen Inc.) for postpartum depression. In August 2023, the U.S. Food and Drug Administration approved Zurzuvae for adults with postpartum depression. The approval was historic in that it represented the first approved oral treatment option for postpartum depression. The launch price of Zurzuvae was announced at $15,900 per course of treatment which consists of a 14-day treatment.

Postpartum depression is commonly treated with selective serotonin reuptake inhibitors (SSRIs). SSRIs may be inadequate for postpartum depression because it can take multiple weeks for depressive symptoms to improve with SSRIs. Additionally, SSRIs are not specifically indicated for postpartum depression and thus clinical trials specific to postpartum depression are scarce. Unlike SSRIs, Zurzuvae is indicated specifically for postpartum depression and trial evidence for Zurzuvae has showed that it can result in quick and significant improvement in depressive symptoms in women with postpartum depression.

Based on our societal impact analysis, we think Zurzuvae could have a positive or neutral impact on all value elements we evaluated. Our generalized cost-effectiveness analysis suggests that zuranolone has the potential to be cost saving over its time in the market. On average, Zurzuvae is expected to reduce discounted non-drug health system costs by $5,500, reduce discounted productivity losses by $3,300, and increase discounted equal value life years by 0.07.

For individuals who take Zurzuvae over its exclusivity period at an assumed price of $15,900 per treatment course, we estimate its cost-effectiveness as approximately $140,000 per equal value life year gained from the health system perspective and approximately $100,000 per equal value life year gained from the societal perspective. This is in line with other published analyses that examined its cost-effectiveness. When considering potential future generic competition and subsequent price drops after the exclusivity period, zuranolone could be cost saving to the health system and to society over its time in the market.

We estimate that the average per-person monetary benefit of Zurzuvae is between $16,000 and $26,000 (see figure below). This range does not represent what we think the price should/could be. Rather, we report this range to show that the launch price of Zurzuvae is beneath it and thus it seems plausible to conclude that the US market-based price for Zurzuvae is defended by its quantifiable societal benefits.

Source: Leerink Center for Pharmacoeconomics postpartum depression model.
Consumers of this information must consider the approach, inputs, and assumptions used in the analysis when interpreting the findings. Read our full report for additional details.

SAD BUT TRUE

Postpartum depression is common and affects the moms of nearly 20% of the births each year. The impact of postpartum depression extends far beyond the mother and beyond the health system.

If left untreated, postpartum depression can negatively impact the mother, partner, and child. Mothers can have worse health, lower rates of breastfeeding, reduced economic productivity, and reduced maternal-infant interactions. Severe cases have been associated with a higher risk of suicide. Partners can experience stress, anxiety, depression, and lost productivity. Children can experience developmental delays, behavioral problems, poor academic performance, and depression.

In a published economic burden study by Dr. Luca and colleagues, the authors reported that perinatal mood and anxiety disorders (PMADs) cost nearly $32,000 per affected mother-child dyad—with the mother experiencing 65% of this cost and the children experiencing 35% of this cost. The costs experienced by the mother are not only attributed to healthcare costs but also reduced productivity. For the children, there are costs associated with preterm birth, suboptimal breastfeeding, sudden infant death syndrome, behavioral and developmental disorders, obesity, asthma, injury, emergency department visits, and nonattendance at well-child visits.

The financial toll of untreated PMADs in the US is huge. Looking only at the births in the year 2017, the study by Dr. Luca and colleagues estimated the financial toll of untreated PMADs as $14 billion. These costs accrued from conception through 5 years postpartum for the 2017 birth cohort and included costs to the mother and child.
The authors conclude that “efforts to lower the prevalence of untreated PMADs could lead to substantial economic savings for employers, insurers, the government, and society.”

SO WHAT

Our analysis of Zurzuvae illustrates four important things:
1. The impact of a prescription drug can extend beyond the individual that receives it,
2. “Not everything that counts can be counted”,
3. The high cost of no treatment, and
4. Patents will eventually expire, allowing for potential long-term affordability/cost savings.

A prescription drug can impact people beyond the individual that receives it. We saw this in our simulation of long-term outcomes for Zurzuvae. Because postpartum depression can impact health and non-health outcomes of a mother’s partner and child(ren), treatments for postpartum depression have the potential to impact health and non-health outcomes of a mother’s partner and child(ren).

“Not everything that counts can be counted”. There is some controversy around who this quote should be attributed to, whether it is Albert Einstein or William Bruce Cameron. It is less controversial to see how this quote applies to our Zurzuvae analysis. There were multiple things we either did not quantify or could not quantify in our analysis, and thus our estimates are likely underestimates. For example, we did not include unemployment attributed to postpartum depression and we did not include any disutility or cost for child educational outcomes. We did not model any life extension associated with a potential lower risk of suicide for the mother. There are likely a host of other things we did not consider in our model that mothers, their partners, and their children cannot ignore.

The cost of no treatment is high. The economic burden study by Dr. Luca and colleagues demonstrates that it isn’t just branded prescription drugs that are often “expensive”. Health conditions are expensive in general. This is why economic modeling (and robust clinical evidence) is so important. A $16,000 price tag for a 14-day treatment might initially sound “expensive”, but when you consider a counterfactual—what would the cost be without treatment—the counterfactual is not $0. Economic models can consider these health sector costs, health outcomes, non-health sector costs, and non-health outcomes to explain why the “expensive” price might actually be a good deal.

Patents will eventually expire, allowing for potential long-term affordability/cost savings. After the exclusivity period for Zurzuvae, generic competition can enter the market. Our cost-effectiveness analysis suggests that if the price of the treatment course drops to less than $5,500 (an approximate 65% discount from the Zurzuvae launch price) with generic competition, then zuranolone could be cost saving to the health system over time. Based on a previous analysis of price declines after branded medicines lose exclusivity, once generics enter the market for oral small molecule drugs, the price has dropped by 74% within 8 months, suggesting that long-term cost savings are a possibility with zuranolone. The price over the exclusivity period may be “high”, but that is intended to be the short-term price for a long-term promise.