HEOR Survival Statistics and Data Shading

𝐖𝐡𝐞𝐧 𝐚 đđ«đźđ  𝐬𝐡𝐹𝐰𝐬 𝐚 đĄđšđłđšđ«đ đ«đšđ­đąđš 𝐹𝐟 𝟎.𝟖𝟎 — 𝐰𝐡𝐱𝐜𝐡 𝐬𝐹𝐼𝐧𝐝𝐬 đąđŠđ©đ«đžđŹđŹđąđŻđž — 𝐚𝐧𝐝 𝐭𝐡𝐞 đ­đ«đąđšđ„ 𝐩𝐞𝐝𝐱𝐚𝐧 đŹđźđ«đŻđąđŻđšđ„ 𝐰𝐚𝐬 𝟏𝟓 𝐩𝐹𝐧𝐭𝐡𝐬 𝐱𝐧 𝐭𝐡𝐞 đœđšđ§đ­đ«đšđ„ đšđ«đŠ, 𝐭𝐡𝐞 𝐩𝐚𝐭𝐡 đ°đšđ«đ€đŹ 𝐹𝐼𝐭 𝐭𝐹 đ«đšđźđ đĄđ„đČ 𝟑 đšđđđąđ­đąđšđ§đšđ„ 𝐩𝐹𝐧𝐭𝐡𝐬 𝐚𝐭 𝐭𝐡𝐞 𝐩𝐞𝐝𝐱𝐚𝐧. 𝐍𝐹𝐭 đČđžđšđ«đŹ. 𝐌𝐹𝐧𝐭𝐡𝐬. 𝐒𝐹𝐩𝐞𝐭𝐱𝐩𝐞𝐬 đ°đžđžđ€đŹ. The drug costs $28,000/month.

If a cancer drug showed “statistically significant survival benefit” in a clinical trial, what does that mean for the patient taking it? It might mean years. It might mean weeks. “Statistically significant” means the result is unlikely to be due to chance. It says nothing about size.

When a drug shows a hazard ratio of 0.80 — which sounds impressive — and the trial median survival was 15 months in the control arm, the math works out to roughly 3 additional months at the median. Not years. Months. Sometimes weeks.

That drug will cost $28,000 a month. It will go through a formulary process in which the manufacturer submits an economic model projecting its value over a 30-year horizon. The model will show, because of the way long-term survival projections work, something that looks considerably larger than 3 months.

A job posting this week describes the consultant hired to build that model: $150 an hour, 8 months, working across clinical, medical, and market access teams to “translate clinical data into inputs for economic models.” The collaboration with the market access team is in the job description. It is not incidental.

The patient navigating prior authorization, step therapy requirements, and cost-sharing for this drug does not know that the economic model justifying its price was built by a consultant hired by the manufacturer, using methods that contain documented directional bias toward favorable framing.

They were told it showed significant survival benefit. It did. Three months at the median. The rest is construction.

The HEOR Director is told “take data from cancer drug trials and feed it into economic models that determine what the drug is worth.” đ‡đžđ«đž’𝐬 𝐰𝐡𝐚𝐭 𝐭𝐡𝐚𝐭 đšđœđ­đźđšđ„đ„đČ đąđ§đŻđšđ„đŻđžđŹ. 𝐓𝐡𝐞 đđ«đźđ  𝐚𝐭 𝐭𝐡𝐞 𝐞𝐧𝐝 𝐹𝐟 𝐭𝐡𝐱𝐬 đ©đ«đšđœđžđŹđŹ 𝐜𝐹𝐬𝐭𝐬 $𝟐𝟖,𝟎𝟎𝟎 𝐚 𝐩𝐹𝐧𝐭𝐡. 𝐓𝐡𝐞 đ­đ«đąđšđ„ 𝐬𝐡𝐹𝐰𝐞𝐝 𝟑 𝐩𝐹𝐧𝐭𝐡𝐬 𝐹𝐟 𝐩𝐞𝐝𝐱𝐚𝐧 đŹđźđ«đŻđąđŻđšđ„ 𝐛𝐞𝐧𝐞𝐟𝐱𝐭. 𝐓𝐡𝐞 đŠđšđđžđ„ 𝐬𝐡𝐹𝐰𝐬 𝐬𝐹𝐩𝐞𝐭𝐡𝐱𝐧𝐠 𝐭𝐡𝐚𝐭 đ„đšđšđ€đŹ đœđšđ§đŹđąđđžđ«đšđ›đ„đČ đŠđšđ«đž đąđŠđ©đ«đžđŹđŹđąđŻđž. 𝐓𝐡𝐚𝐭 𝐱𝐬 𝐰𝐡𝐚𝐭 𝐭𝐡𝐱𝐬 𝐣𝐹𝐛 𝐱𝐬 đŸđšđ«.

Cancer drug trials run for 3–5 years. Economic models that justify drug prices need to project 5–10 years into the future beyond the clinical follow-up end date, because that’s what payers require. The gap between what the trial observed and what the model projects is filled by statistical extrapolation — a mathematical technique that extends the survival curve beyond the data.

Different extrapolation methods, fitted to the same trial data, can produce radically different long-term projections. A drug that extended median survival by 3 months in a trial might look, in one model, like it extends 10-year survival by 6 percentage points — or, in a different equally valid model, by 1 percentage point. The QALY gain, and therefore the justifiable price, differs by a factor of six depending on which model gets selected.

The person being hired makes that selection. They also select how transition probabilities move patients between health states in the model, which quality-of-life weights to apply, and how to model the costs the drug allegedly saves the health system.

Each choice is defensible. The aggregate is not neutral.

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