Independent Market Access and Reimbursement Risk Assessment.

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Somatrogon for treating growth disturbance in children and young people aged 3 years and over

As of February 2023, MARA’s assessment finds Somatrogon’s reimbursement risk concentrated in quality of life, with cost effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs safety and adverse effects: what harms arrive alongside the benefit, which payers set against the gains before funding a treatment. The strength recorded in cost effectiveness carries weight because that domain asks whether the price asked stands in a defensible relationship to the benefit delivered — the core of most European reimbursement decisions.

Endocrinology

This rating sits within MARA’s Endocrinology coverage, alongside 9 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — Clinical effectiveness

Somatrogon is reported to be as effective as one preparation of somatropin (Genotropin) for treating growth disturbance caused by growth hormone deficiency. This indicates a clear clinical advantage with significant improvement in primary outcomes compared to the standard of care.

Does the economic case hold at the expected price? — Cost effectiveness

The cost comparison suggests that the costs of somatrogon are similar to those of existing somatropin preparations, indicating it is clearly cost-effective under common thresholds with manageable uncertainty.

Is there quality-of-life evidence payers weigh? — Quality of life

While the document does not provide specific HRQoL data, it implies that somatrogon is a suitable treatment option. However, there is no mention of validated tools showing significant improvements in quality of life, leading to a rating of minimal impact.

Does the safety profile hold up for payers? — Safety and Adverse Effects

The document does not highlight any significant safety concerns or adverse effects associated with somatrogon, suggesting an acceptable safety profile with manageable adverse events.

Was the drug compared against what payers expect? — Comparator Selection

Somatrogon was compared against somatropin, which is the standard treatment for growth hormone deficiency. This indicates a very good selection of comparators with minor gaps.

Is the population defined the way payers need it? — Patient Population and Subgroups

The patient population for somatrogon includes children and adolescents aged 3 years and over with growth hormone deficiency, which is a relevant and representative group for the treatment being assessed.

Does the drug fit how care is delivered and paid for? — Care Pathway Integration

Somatrogon is a weekly injection compared to daily somatropin, which may simplify administration. This indicates minor adjustments needed for integration into existing care pathways.

Are the wider system costs understood? — Resource Use and Cost Implications

The estimated annual cost for a patient is around £9,500, which is justifiable given the comparable costs to existing treatments and the expected benefits.

Would the evidence survive payer scrutiny? — Evidence Quality and Robustness

The evidence presented is based on clinical trials showing effectiveness comparable to somatropin, indicating acceptable evidence quality with some methodological concerns.

How exposed is the case to uncertainty? — Uncertainty, Sensitivity, and Broader Impacts

The document indicates a favorable context for somatrogon, with manageable uncertainties regarding its implementation and cost-effectiveness.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
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